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

Sponsors and collaborators

Shady Grove Fertility Reproductive Science Center

Lead sponsor

EMD Serono

Collaborator

Source ClinicalTrials.gov