Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:07 AM
Ignite Modification Date:
2025-12-25 @ 3:07 AM
NCT ID:
NCT04163133
Eligibility Criteria:
Inclusion Criteria:
* Age: ≥18 and \<35 years old
* AFC: ≥5 and \<20
* AMH: ≥1.1 ng/mL and \<2.5 ng/mL
* BMI: ≥18.5 Kg/m2 and \<29 Kg/m
* First or second ART cycle
* Regular menstrual cycles (between 22 and 35 days)
* Two ovaries present
* Planned for single or double day 3 transfer
* Infertile couples scheduled for their first IVF/ICSI cycle with fixed antagonist protocol.
* Informed consent obtained.
Exclusion Criteria:
* Women with contraindication for IVF or ICSI, such as poorly controlled type 1 or type 2 diabetes mellitus; undiagnosed liver disease or dysfunction (based on serum liver enzyme test results); renal disease or abnormal serum renal function; significant anemia; history of deep venous thrombosis, pulmonary embolus or cerebrovascular accident; uncontrolled hypertension or known symptomatic heart disease; history of (or suspected) cervical carcinoma, endometrial carcinoma or breast carcinoma; and undiagnosed vaginal bleeding.
* Previous history of poor ovarian response (\<4 oocytes retrieved) with a maximal dose of OS (≥300 IU/day) or OHSS, regardless of gonadotropin dose
* Known reasons for impaired implantation (i.e. hydrosalpinx, fibroid distorting the endometrial cavity, Asherman's syndrome, thrombophilia or endometrial tuberculosis)
* Repeated miscarriages (\>2 previous biochemical pregnancies or \>2 spontaneous miscarriages)
* Recurrent implantation failure (\>3 failed cycles with good quality embryos)
* PCOS
* Untreated thyroid disfunction
* Administration of exogenous E2, P4 or gonadotropins in the preceding menstrual cycle
* Active female smoking
* Ongoing pregnancy
* Women who have previously enrolled in the trial
* Those unable to comprehend the investigational nature of the proposed study
* either male partner or female partner has to receive donor sperm or donor eggs.
* Either male partner or female partner has to receive PGD and PGS.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT04163133
Study Brief:
Protocol Section:
NCT04163133