Recruiting

CHC

Sponsor:

Shady Grove Fertility Reproductive Science Center

Code:

NCT07225660

Conditions

Fertility Preservation

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Not accepted

Interventions

OCP pause

Study Details

Brief 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).

Conditions

Fertility Preservation

Study ID

NCT07225660

Start date

Feb 25, 2026

Status verified date

Feb, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

394 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

OCP pause

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

Primary outcome measure

  • Oocyte maturation rate [ Time Frame: During oocyte retrieval ]
  • Number of oocytes retrieved [ Time Frame: During oocyte retrieval ]

Central Contacts and Locations

Central contacts

Tasha Newsome, Clinical Research Supervisor

301-545-1289Tasha.Newsome@sgfertility.com

Seth J Barishansky, MD

475-267-9469HolidayStudy@USFertility.com

Locations

Yale Fertility Center

Recruiting

Orange, Connecticut, United States, 06477

Contacts

Seth J Barishansky, MD

475-267-9469HolidayStudy@USFertility.com

Shady Grove Fertility Rockville

Recruiting

Rockville, Maryland, United States, 20850

Contacts

Tasha Newsome, 301-545-1289

301-545-1289Tasha.Newsome@sgfertility.com

Amalia Namath, MD

HolidayStudy@USFertility.com

More Information

Sponsor

Shady Grove Fertility Reproductive Science Center

Last update posted

Mar 2, 2026

Last verified

Feb, 2026

Keywords

  • planned oocyte cryopreservation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by Shady Grove Fertility Reproductive Science Center on 2026-03-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.