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

NCT07225660 | Recruiting

• 1 other identifier: Pro00090115
• Study Type: interventional
• Target: 394
• Locations: 1 country
• Sites: 3

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

Keywords

planned oocyte cryopreservation

Outcome Measures

Primary Outcomes (2)

• Oocyte maturation rate

  Median number of percentage of vitrified MII oocytes yielded per cycle

  During oocyte retrieval

• Number of oocytes retrieved

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

  During oocyte retrieval

Secondary Outcomes (1)

• AMH levels

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

Study Arms (2)

Holiday

OTHER

Patients will undergo a 2 month drug holiday (pause) with combined hormonal contraceptives prior to planned oocyte cryopreservation

Other: OCP pause

Immediate Start

NO INTERVENTION

Patients will immediately begin planned oocyte cryopreservation after discontinuation of prolonged combined hormonal contraceptive

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

Holiday

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Ovary-bearing individuals 18 to 40 years of age.
• BMI \< 40 kg/m2
• Non-smoker for at least 3 months prior to study enrollment.

You may not qualify if:

• BMI greater than or equal to 40 kg/m2
• Current Smoker
• Any contraindications to ovarian stimulation or outpatient egg retrieval under anesthesia

Sponsors & Collaborators

• Shady Grove Fertility Reproductive Science Center: lead
• EMD Serono: collaborator

Study Sites (3)

Yale Fertility Center

Orange, Connecticut, 06477, United States

RECRUITING

Shady Grove Fertility Rockville

Rockville, Maryland, 20850, United States

RECRUITING

Reproductive Medicine Associates of New York

New York, New York, 10022, United States

NOT YET RECRUITING

Related Publications (16)

• Cohen BL, Katz M. Further studies on pituitary and ovarian function in women receiving hormonal contraception. Contraception. 1981 Aug;24(2):159-72. doi: 10.1016/0010-7824(81)90089-5.

  PMID: 6794980 BACKGROUND

• Wan LS, Ganguly M, Weiss G. Pituitary response to LHRH stimulation in women on oral contraceptives: a followup dose response study. Contraception. 1981 Sep;24(3):229-34. doi: 10.1016/0010-7824(81)90035-4.

  PMID: 6796328 BACKGROUND

• Yu Ng EH, Chi Wai Chan C, Tang OS, Shu Biu Yeung W, Chung Ho P. Effect of pituitary downregulation on antral follicle count, ovarian volume and stromal blood flow measured by three-dimensional ultrasound with power Doppler prior to ovarian stimulation. Hum Reprod. 2004 Dec;19(12):2811-5. doi: 10.1093/humrep/deh500. Epub 2004 Sep 9.

  PMID: 15358718 BACKGROUND

• Tran ND, Aghajanova L, Kao CN, Cedars MI, Rosen MP. Impact of pituitary suppression on antral follicle count and oocyte recovery after ovarian stimulation. Fertil Steril. 2016 Mar;105(3):690-696. doi: 10.1016/j.fertnstert.2015.11.033. Epub 2015 Dec 13.

  PMID: 26696299 BACKGROUND

• Cohen BL, Katz M. Pituitary and ovarian function in women receiving hormonal contraception. Contraception. 1979 Nov;20(5):475-87. doi: 10.1016/0010-7824(79)90053-2.

  PMID: 393456 BACKGROUND

• Daniels K, Abma JC. Current Contraceptive Status Among Women Aged 15-49: United States, 2017-2019. NCHS Data Brief. 2020 Oct;(388):1-8.

  PMID: 33151146 BACKGROUND

• Schattman GL. Cryopreservation of Oocytes. Author replies. N Engl J Med. 2016 Jan 21;374(3):288. doi: 10.1056/NEJMc1515128. No abstract available.

  PMID: 26789885 BACKGROUND

• Doyle JO, Richter KS, Lim J, Stillman RJ, Graham JR, Tucker MJ. Successful elective and medically indicated oocyte vitrification and warming for autologous in vitro fertilization, with predicted birth probabilities for fertility preservation according to number of cryopreserved oocytes and age at retrieval. Fertil Steril. 2016 Feb;105(2):459-66.e2. doi: 10.1016/j.fertnstert.2015.10.026. Epub 2015 Nov 18.

  PMID: 26604065 BACKGROUND

• Cil AP, Bang H, Oktay K. Age-specific probability of live birth with oocyte cryopreservation: an individual patient data meta-analysis. Fertil Steril. 2013 Aug;100(2):492-9.e3. doi: 10.1016/j.fertnstert.2013.04.023. Epub 2013 May 24.

  PMID: 23706339 BACKGROUND

• Mesen TB, Mersereau JE, Kane JB, Steiner AZ. Optimal timing for elective egg freezing. Fertil Steril. 2015 Jun;103(6):1551-6.e1-4. doi: 10.1016/j.fertnstert.2015.03.002. Epub 2015 Apr 14.

  PMID: 25881876 BACKGROUND

• Rudick B, Opper N, Paulson R, Bendikson K, Chung K. The status of oocyte cryopreservation in the United States. Fertil Steril. 2010 Dec;94(7):2642-6. doi: 10.1016/j.fertnstert.2010.04.079. Epub 2010 Jun 18.

  PMID: 20723535 BACKGROUND

• Noyes N, Porcu E, Borini A. Over 900 oocyte cryopreservation babies born with no apparent increase in congenital anomalies. Reprod Biomed Online. 2009 Jun;18(6):769-76. doi: 10.1016/s1472-6483(10)60025-9.

  PMID: 19490780 BACKGROUND

• Hansen KR, Knowlton NS, Thyer AC, Charleston JS, Soules MR, Klein NA. A new model of reproductive aging: the decline in ovarian non-growing follicle number from birth to menopause. Hum Reprod. 2008 Mar;23(3):699-708. doi: 10.1093/humrep/dem408. Epub 2008 Jan 11.

  PMID: 18192670 BACKGROUND

• Sozou PD, Hartshorne GM. Time to pregnancy: a computational method for using the duration of non-conception for predicting conception. PLoS One. 2012;7(10):e46544. doi: 10.1371/journal.pone.0046544. Epub 2012 Oct 4.

  PMID: 23056338 BACKGROUND

• Dunson DB, Baird DD, Colombo B. Increased infertility with age in men and women. Obstet Gynecol. 2004 Jan;103(1):51-6. doi: 10.1097/01.AOG.0000100153.24061.45.

  PMID: 14704244 BACKGROUND

• Faddy MJ, Gosden RG, Gougeon A, Richardson SJ, Nelson JF. Accelerated disappearance of ovarian follicles in mid-life: implications for forecasting menopause. Hum Reprod. 1992 Nov;7(10):1342-6. doi: 10.1093/oxfordjournals.humrep.a137570.

  PMID: 1291557 BACKGROUND

Central Study Contacts

Tasha Newsome, Clinical Research Supervisor

CONTACT

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

Seth J Barishansky, MD

CONTACT

475-267-9469; HolidayStudy@USFertility.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director and Chief Research Officer, USFertility

Study Record Dates

• First Submitted: November 4, 2025
• First Posted: November 10, 2025
• Study Start: February 25, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)