Health Trials

Hormonal Optimization: Late vs. Immediate Start After Discontinuation of Oral Contraceptives in Assisted Reproductive technologY (HOLIDAY)

ConditionFertility Preservation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorShady Grove Fertility Reproductive Science Center

About this trial

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).

Eligibility criteria

Qualifiers

Ovary-bearing individuals 18 to 40 years of age.

BMI < 40 kg/m2

Non-smoker for at least 3 months prior to study enrollment.

Disqualifiers

BMI greater than or equal to 40 kg/m2

Current Smoker

Any contraindications to ovarian stimulation or outpatient egg retrieval under anesthesia

Trial design

Treatments tested in this trial

  • OCP pause

Treatment groups

394 Participants
are divided into 2 treatment groups

Locations

3
Yale Fertility Center06477, OrangeConnecticut, United States
Shady Grove Fertility Rockville20850, RockvilleMaryland, United States
Reproductive Medicine Associates of New York10022, New YorkNew York, United States

Sponsors and collaborators

Shady Grove Fertility Reproductive Science Center

Lead sponsor

EMD Serono

Collaborator

Source ClinicalTrials.gov