Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • OCP pause

    Other intervention

    Subjects in the study arm will be asked to discontinue combined hormonal contraceptives (CHC) for 2 months prior to planned oocyte cryopreservation

Treatment groups

394 Participants
are divided into 2 treatment groups
Group A: HolidayOther 1 intervention
Group B: Immediate StartNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Oocyte maturation rate

Median number of percentage of vitrified MII oocytes yielded per cycle

Time frame
During oocyte retrieval
2

Number of oocytes retrieved

The median number of cumulus-oocyte complexes (COC) retrieved during oocyte retrieval

Time frame
During oocyte retrieval

Secondary outcomes

1

AMH levels

Differences in AMH levels from baseline to cycle start

Time frame
AMH level differences from baseline to post-drug holiday (2 months)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shady Grove Fertility Reproductive Science Center

Lead sponsor

EMD Serono

Collaborator

Source ClinicalTrials.gov
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