A Randomized Blinded Controlled Trial Assessing Hormonal Optimization: Late vs. Immediate Start After Discontinuation of Oral Contraceptives in Assisted Reproductive technologY (HOLIDAY)
Shady Grove Fertility Reproductive Science Center
Summary
HOLIDAY is a two-arm, parallel-group, multi-center, randomized trial in which subjects undergoing planned oocyte cryopreservation will be randomized to receive either a 2-month pause of Combined Hormonal Contraceptives (CHC) or immediate start (without a pause).
Description
Reproductive aging in women is a continuous process that begins prior to birth and extends until menopause. The primary mechanism behind this process is the depletion of the ovarian pool of non-growing follicles (NGFs). Previous models, such as the biphasic-exponential model, have postulated that female fertility prominently declines with age, significantly after age 32, and with a more accelerated rate after age 35. Newer models of ovarian follicular depletion predict no sudden change in decay rate but rather a constantly, increasing rate. With the advent of vitrification, oocyte cryopreserv…
Eligibility
- Age range
- 18–40 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 1. Ovary-bearing individuals 18 to 40 years of age. 2. BMI \< 40 kg/m2 3. Non-smoker for at least 3 months prior to study enrollment. Exclusion Criteria: 1. BMI greater than or equal to 40 kg/m2 2. Current Smoker 3. Any contraindications to ovarian stimulation or outpatient egg retrieval under anesthesia
Interventions
- OtherOCP pause
Subjects in the study arm will be asked to discontinue combined hormonal contraceptives (CHC) for 2 months prior to planned oocyte cryopreservation
Locations (3)
- Yale Fertility CenterOrange, Connecticut
- Shady Grove Fertility RockvilleRockville, Maryland
- Reproductive Medicine Associates of New YorkNew York, New York