Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-31 @ 12:19 AM
Study NCT ID:
NCT07348757
Status:
RECRUITING
Last Update Posted:
2026-02-03
First Post:
2025-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
rFSH vs rFSH+rLH in Dydrogesterone-Based Progestin Protocol: A Prospective Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'targetDuration': '9 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-05-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-31', 'studyFirstSubmitDate': '2025-11-19', 'studyFirstSubmitQcDate': '2026-01-09', 'lastUpdatePostDateStruct': {'date': '2026-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mature oocytes collected (MII)', 'timeFrame': 'The overall assessment period spans the duration of ovarian stimulation and scheduling of oocyte aspiration, with a maximum observation period of up to 3-4 weeks', 'description': 'Time Frame:\n\nFrom the date of participant enrollment, including initiation of controlled ovarian stimulation, through the completion of the oocyte pick-up (OPU) procedure, with the number of mature (metaphase II) oocytes assessed and recorded exclusively at the time of oocyte aspiration. The overall assessment period spans the duration of ovarian stimulation and scheduling of OPU, with a maximum observation period of up to 3-4 weeks'}], 'secondaryOutcomes': [{'measure': 'total numbers of blastocysts', 'timeFrame': 'From participant enrollment and initiation of ovarian stimulation through completion of embryo culture to the blastocyst stage, over a maximum period of up to 3-4 weeks.', 'description': 'The total number of blastocyst-stage embryos generated per cycle, defined as embryos that reach the blastocyst stage (Day 5 or Day 6) following in vitro fertilization or intracytoplasmic sperm injection (ICSI), and recorded after completion of embryo culture.\n\nTime Frame\n\nFrom the date of participant enrollment, including initiation of controlled ovarian stimulation, through completion of embryo culture to the blastocyst stage, with the total number of blastocysts assessed and recorded after final blastocyst evaluation (Day 5-6 embryo culture). The overall assessment period includes ovarian stimulation, oocyte pick-up (OPU), fertilization, and extended embryo culture, with a maximum observation period of up to 3-4 weeks.'}, {'measure': 'numbers of top quality blastocysts', 'timeFrame': 'Day 5 after fertilization', 'description': 'Top-quality blastocysts are defined according to the Gardner and Schoolcraft blastocyst grading system as blastocysts with full expansion (grade ≥3), an inner cell mass (ICM) grade of A or B, and a trophectoderm (TE) grade of A or B (i.e., grades ≥3BB)'}, {'measure': 'Clinical pregnancy rate per embryo transfer', 'timeFrame': '6-7 weeks after embryo transfer', 'description': 'Clinical pregnancy rate per embryo transfer is defined as the proportion of embryo transfer cycles resulting in at least one intrauterine gestational sac with fetal cardiac activity confirmed by transvaginal ultrasound.\n\nUnit: %'}, {'measure': 'Live birth rate per embryo transfer (LBR per ET)', 'timeFrame': 'At delivery', 'description': 'Live birth rate per embryo transfer is defined as the proportion of embryo transfer cycles resulting in the delivery of at least one live-born infant after ≥24 weeks of gestation.\n\nUnit: percentage'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gonadotropins', 'invitro fertilization', 'pregnancy', 'ppos'], 'conditions': ['InVitro Fertilization', 'Gonadotropins']}, 'referencesModule': {'references': [{'pmid': '40524846', 'type': 'BACKGROUND', 'citation': 'Muharam R, Nurdya AN, Yo EC, Sumapraja K, Harzif AK, Maidarti M, Wiweko B, Hestiantoro A. Comparing Dydrogesterone Versus Medroxyprogesterone in Progestin-Primed Ovarian Stimulation (PPOS) for Patients Undergoing In Vitro Fertilization/Intracytoplasmic Sperm Injection: A Systematic Review. Cureus. 2025 Jun 13;17(6):e85959. doi: 10.7759/cureus.85959. eCollection 2025 Jun.'}, {'pmid': '34630325', 'type': 'BACKGROUND', 'citation': 'Zhang J, Du M, Li Z, Liu W, Ren B, Zhang Y, Guan Y. Comparison of Dydrogesterone and Medroxyprogesterone in the Progestin-Primed Ovarian Stimulation Protocol for Patients With Poor Ovarian Response. Front Endocrinol (Lausanne). 2021 Sep 24;12:708704. doi: 10.3389/fendo.2021.708704. eCollection 2021.'}, {'pmid': '29300975', 'type': 'BACKGROUND', 'citation': 'Yu S, Long H, Chang HY, Liu Y, Gao H, Zhu J, Quan X, Lyu Q, Kuang Y, Ai A. New application of dydrogesterone as a part of a progestin-primed ovarian stimulation protocol for IVF: a randomized controlled trial including 516 first IVF/ICSI cycles. Hum Reprod. 2018 Feb 1;33(2):229-237. doi: 10.1093/humrep/dex367.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to compare two commonly used hormone treatments for women undergoing IVF. All participants will receive a stimulation protocol that includes dydrogesterone, a medication used to safely control natural hormone surges during treatment. The study will observe women who are treated either with recombinant FSH alone or with a combination of recombinant FSH and recombinant LH-both routinely used options in our clinic.\n\nInvestigators will prospectively monitor how these treatments affect the growth of ovarian follicles, the number of mature eggs collected, the quality of developing embryos, and early pregnancy outcomes. No additional procedures or medications will be required beyond standard IVF care. The goal is to better understand whether adding recombinant LH provides any measurable benefit in dydrogesterone-based PPOS cycles.', 'detailedDescription': 'This prospective observational study aims to evaluate how two routinely used gonadotropin strategies influence ovarian response and reproductive outcomes in women undergoing IVF treatment with a dydrogesterone-based Progestin-Primed Ovarian Stimulation (PPOS) protocol. In standard clinical practice, ovarian stimulation may be performed using recombinant FSH alone or a combination of recombinant FSH and recombinant LH. Both approaches are already used in daily care, and the choice of regimen is determined by the treating physician according to individual patient characteristics. The study does not assign treatments; instead, it observes and compares outcomes in patients receiving these medications as part of routine management.\n\nDydrogesterone is administered from Day 2 of the cycle to prevent premature LH surges, allowing controlled follicular growth. Participants will undergo regular ultrasound monitoring and bloodwork as part of their usual IVF treatment. When appropriate follicular maturation is achieved, final oocyte maturation will be triggered, followed by oocyte retrieval according to standard clinical protocols.\n\nThe primary focus of this study is to compare the number of mature (MII) oocytes obtained between the two gonadotropin regimens. Secondary outcomes include the number of good-quality blastocysts, implantation rate, and ongoing pregnancy rate, which together provide a comprehensive assessment of IVF success. Additional stimulation characteristics-such as follicle growth patterns, estradiol and LH levels, total gonadotropin dose, and duration of stimulation-will also be documented to explore differences in cycle dynamics.\n\nNo extra medications, procedures, or interventions will be required beyond routine IVF care. All data will be collected prospectively and analyzed to determine whether adding recombinant LH offers measurable clinical advantages compared with recombinant FSH alone in dydrogesterone-PPOS cycles.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '43 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be selected from women seeking infertility treatment at a fertility clinic and undergoing in-vitro fertilization (IVF) with controlled ovarian stimulation. This population typically consists of reproductive-age women who have difficulty achieving pregnancy and require assisted reproductive technologies. Eligible patients are generally healthy enough to undergo ovarian stimulation, have adequate ovarian reserve (AMH \\> 1 ng/mL), and meet age and BMI criteria for standard IVF care. Women in this group routinely receive dydrogesterone-based PPOS protocols as part of their clinical treatment, and the choice of gonadotropin regimen (rFSH alone or rFSH+rLH) follows routine medical practice. This population reflects real-world patients commonly treated in IVF programs', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 20 to 43 years.\n* BMI \\< 30 kg/m².\n* AMH \\> 1 ng/mL.\n* Undergoing IVF/ICSI treatment with a dydrogesterone-based PPOS protocol.\n* Women with regular menstrual cycles or clinically acceptable cycle pattern for stimulation.\n* Ability to provide informed consent and comply with study procedures.\n* Presence of at least one ovary and eligibility for controlled ovarian stimulation\n\nExclusion Criteria:\n\n* Cycle cancellation due to lack of viable embryos.\n* Prior or planned PGT-A in the same cycle.\n* Adenomyosis diagnosed by ultrasound or MRI.\n* Uncorrected uterine anomalies (e.g., bicornuate, unicornuate, didelphys uterus).\n* Presence of hydrosalpinx.\n* Use of oral contraceptives or luteal-phase estradiol within 3 months before stimulation.\n* Refusal or inability to provide informed consent.\n* Severe systemic disease or contraindication to ovarian stimulation.\n* Prior bilateral oophorectomy'}, 'identificationModule': {'nctId': 'NCT07348757', 'acronym': 'DYG-GONA', 'briefTitle': 'rFSH vs rFSH+rLH in Dydrogesterone-Based Progestin Protocol: A Prospective Study', 'organization': {'class': 'OTHER', 'fullName': 'Centrum Clinic IVF Center'}, 'officialTitle': 'Comparison of rFSH Alone Versus rFSH+rLH in Dydrogesterone-Based Progestin Protocol Cycles', 'orgStudyIdInfo': {'id': '2025-11'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Recombinant FSH Only Group', 'description': 'Recombinant FSH (rFSH) Group - Additional Information\n\nParticipants in this cohort will undergo ovarian stimulation using recombinant follicle-stimulating hormone (rFSH) alone, following routine IVF clinical practice. Dydrogesterone will be initiated on Cycle Day 2 as part of the standard PPOS (Progestin-Primed Ovarian Stimulation) protocol to prevent premature LH surge. Follicular development will be monitored with ultrasound and serum hormone levels, and the timing of final oocyte maturation and oocyte pick-up will follow standard clinical procedures. No additional medications or interventions will be administered beyond those routinely used for IVF treatment.'}, {'label': 'Recombinant FSH Plus Recombinant LH Group', 'description': 'Recombinant FSH Plus Recombinant LH (2:1 Combination) Group - Additional Information\n\nParticipants in this cohort will receive a combination of recombinant follicle-stimulating hormone (rFSH) and recombinant luteinizing hormone (rLH) in a fixed 2:1 ratio, as routinely used in clinical IVF practice. Dydrogesterone will be initiated on Cycle Day 2 according to the standard PPOS (Progestin-Primed Ovarian Stimulation) protocol to prevent premature LH surge. Follicular development will be monitored through ultrasound examinations and serum hormone measurements, and final oocyte maturation and oocyte retrieval will be performed following standard clinical procedures. No additional treatments or study-specific interventions will be administered beyond those normally used in IVF care.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06800', 'city': 'Ankara', 'state': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Emre G Pabuccu, Prof.', 'role': 'CONTACT', 'email': 'emregpabuccu@gmail.com', 'phone': '05324147844'}, {'name': 'Recai Pabuccu, Prof.', 'role': 'CONTACT', 'email': 'rpabuccu@hotmail.com', 'phone': '0090 532 6160086'}, {'name': 'Emre G pabuçcu, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centrum Clinic IVF Center', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'facility': 'Bahçeci IVF Center', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Emre G pabuçcu, Professor', 'role': 'CONTACT', 'email': 'emregpabuccu@gmail.com', 'phone': '+905324147844'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared because the study involves sensitive reproductive health information and data are collected solely for clinical and research purposes within the center. Only aggregated, de-identified results will be reported in publications.\n\nSupporting Documents to Be Shared: None.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centrum Clinic IVF Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Emre Göksan Pabuçcu', 'investigatorAffiliation': 'Centrum Clinic IVF Center'}}}}