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

Conditions

• Fertility Preservation

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 40 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date

Feb 25, 2026

Status verified

Feb 2026

Primary completion

Jun 1, 2027

Completion

Jul 1, 2027

Study Design

Enrollment

394 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Other: Holiday
  Patients will undergo a 2 month drug holiday (pause) with combined hormonal contraceptives prior to planned oocyte cryopreservation
• No Intervention: Immediate Start
  Patients will immediately begin planned oocyte cryopreservation after discontinuation of prolonged combined hormonal contraceptive

Primary Outcome Measure

Oocyte maturation rate [ Time Frame: During oocyte retrieval ]

Central Contacts

• Tasha Newsome, Clinical Research Supervisor
  301-545-1289
  [email protected]
• Seth J Barishansky, MD
  475-267-9469
  [email protected]

Locations (3)

Find similar trials in Orange, CT

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