Ignite Creation Date:
2024-07-17 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06486870
Status:
COMPLETED
Last Update Posted:
2024-07-05
First Post:
2024-06-27
Brief Title:
Comparison Between Two Ovulation Induction Therapies and LOD on Clinical Outcomes in CC-Resistant PCOS Women
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Comparative Study Between Two Ovulation Induction Therapies and Laparoscopic Ovarian Drilling on Clinical Outcomes in Clomiphene Citrate-Resistant PCOS Women
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Polycystic ovary syndrome PCOS is a prevalent endocrine disorder affecting 4-8 of reproductive-aged women and is a leading cause of infertility due to oligo-anovulation 1 Studies suggest a higher prevalence of 178-199 based on Rotterdam diagnostic criteria PCOS is diagnosed by the presence of at least two out of three criteria oligo- andor anovulation hyperandrogenism and polycystic ovaries with other etiologies excluded 2 Clomiphene citrate CC a selective estrogen receptor modulator has been the first-line treatment for inducing ovulation in anovulatory women with PCOS for decades Approximately 80 of women resume ovulation with CC but only 35-40 achieve pregnancy About 15-40 of women are resistant to CC defined as failure to ovulate after receiving a maximum dosage of 150 mg per day for 5 days starting on the third day of the menstrual cycle For CC-resistant women metformin an insulin sensitizer has been explored but shows limited effectiveness except in combination with CC Gonadotropins are the standard treatment for CC-resistant PCOS but come with risks of multiple pregnancies and ovarian hyperstimulation syndrome OHSS 3 Letrozole an aromatase inhibitor is another treatment option that prevents the conversion of androgens to estrogen thereby increasing gonadotropin-releasing hormone GnRH secretion and promoting ovulation Letrozole has shown superior ovulation and live birth rates compared to CC and is now recommended as the first-line treatment for anovulation in women with PCOS It has comparable rates of OHSS and miscarriage to CC but fewer relevant studies have compared it directly to laparoscopic ovarian drilling LOD 4 LOD is an alternative to gonadotropins for inducing ovulation in CC-resistant PCOS It involves surgical intervention which can be either unilateral or bilateral and is effective without the risks of multiple pregnancies or OHSS LOD also increases ovarian responsiveness to CC Despite minimal morbidity LOD can lead to tubo-ovarian adhesions and premature ovarian failure although these risks are reduced by careful technique 5
Detailed Description:
Materials and Methods
Design A randomized clinical study to evaluate and compare the effects of gonadotropins Letrozole and unilateral laparoscopic ovarian drilling in infertile women with PCOS Conducted at Kasr El Aini Maternity Hospital Cairo University gynecological and infertility clinics
Patients The study includes infertile women aged 20-35 years with PCOS referred to the gynecology and infertility clinics of the Department of Obstetrics and Gynecology Kasr Ainy Hospital Cairo University Women diagnosed with PCOS based on the Rotterdam criteria ovulatory disturbance hyperandrogenism and the presence of more than 12 follicles 2-9 mm in diameter in each ovary by ultrasound examination are randomly assigned to one of three groups Letrozole G1 Gonadotropin G2 or Laparoscopic Unilateral Ovarian Drilling G3 based on a computer-generated random number sequence Side effects for each intervention are registered
Treatment Protocol
Group I G1 Letrozole 25 mg oral tablets administered from the fifth day of menses for 5 days repeated for up to six cycles
Group II G2 Human menopausal gonadotropin hMG starts on cycle day three 75 IU every other day aiming for mono-ovulation Monitoring through transvaginal ultrasound begins on cycle day nine The hMG dose is adjusted based on follicular response Cycles are cancelled for under or over-response
Group III G3 Laparoscopic ovarian drilling with electrocautery mixed current monopolar electrosurgical needle 4-point cauterization each for 4 seconds 40 W 3 mm diameter 4 mm depth on one ovary
Follow-Up Patients will be monitored for six months post-intervention Hormonal profiles will be reassessed at the end of the study period Statistical analyses will be performed using Microsoft Excel 2007 and IBM SPSS version 22 A p-value 005 will be considered statistically significant
Design A randomized clinical study to evaluate and compare the effects of gonadotropins Letrozole and unilateral laparoscopic ovarian drilling in infertile women with PCOS Conducted at Kasr El Aini Maternity Hospital Cairo University gynecological and infertility clinics
Patients The study includes infertile women aged 20-35 years with PCOS referred to the gynecology and infertility clinics of the Department of Obstetrics and Gynecology Kasr Ainy Hospital Cairo University Women diagnosed with PCOS based on the Rotterdam criteria ovulatory disturbance hyperandrogenism and the presence of more than 12 follicles 2-9 mm in diameter in each ovary by ultrasound examination are randomly assigned to one of three groups Letrozole G1 Gonadotropin G2 or Laparoscopic Unilateral Ovarian Drilling G3 based on a computer-generated random number sequence Side effects for each intervention are registered
Treatment Protocol
Group I G1 Letrozole 25 mg oral tablets administered from the fifth day of menses for 5 days repeated for up to six cycles
Group II G2 Human menopausal gonadotropin hMG starts on cycle day three 75 IU every other day aiming for mono-ovulation Monitoring through transvaginal ultrasound begins on cycle day nine The hMG dose is adjusted based on follicular response Cycles are cancelled for under or over-response
Group III G3 Laparoscopic ovarian drilling with electrocautery mixed current monopolar electrosurgical needle 4-point cauterization each for 4 seconds 40 W 3 mm diameter 4 mm depth on one ovary
Follow-Up Patients will be monitored for six months post-intervention Hormonal profiles will be reassessed at the end of the study period Statistical analyses will be performed using Microsoft Excel 2007 and IBM SPSS version 22 A p-value 005 will be considered statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None