Further studies on pituitary and ovarian function in women receiving hormonal contraception.
B L Cohen, M Katz
https://pubmed.ncbi.nlm.nih.gov/6794980Actively Recruiting
Phase Not Applicable
Age: 18Years - 40Years
FEMALE
ID07225660
A Randomized Blinded Controlled Trial Assessing Hormonal Optimization: Late vs. Immediate Start After Discontinuation of Oral Contraceptives in Assisted Reproductive Technology (HOLIDAY)
Led by Shady Grove Fertility Reproductive Science Center · Updated on 2026-03-02
394
Participants Needed
3
Research Sites
4 weeks
Total Duration
On this page
Sponsors
S
Shady Grove Fertility Reproductive Science Center
Lead Sponsor
E
EMD Serono
Collaborating Sponsor
AI-Summary
What this Trial Is About
This trial investigates how pausing combined hormonal contraceptives (CHC) affects planned egg freezing in women aged 18 to 40. Researchers are studying whether a 2-month break from CHC before starting ovarian stimulation leads to more eggs retrieved compared to starting immediately after stopping CHC. The study aims to understand if hormonal contraceptive use suppresses ovarian reserve markers and affects egg yield during fertility preservation. Participants will be randomly assigned to one of two groups: one will take a 2-month break from CHC before egg freezing, and the other will start ovarian stimulation right after stopping CHC. Both groups will undergo planned oocyte cryopreservation procedures. This is a multi-center, randomized, quadruple-blind trial comparing these two approaches to optimize fertility preservation protocols. During the study, participants will have ovarian reserve markers like Anti-Müllerian hormone (AMH) measured before and after the drug holiday. The main outcomes measured are the number of eggs retrieved and the maturation rate of these eggs during retrieval. The study also monitors changes in AMH levels over 2 months. Participants will be assessed through blood tests and egg retrieval procedures, with safety and procedure tolerance followed throughout the trial.
CONDITIONS
Brief Title
Hormonal Optimization: Late vs. Immediate Start After Discontinuation of Oral Contraceptives in Assisted Reproductive technologY (HOLIDAY)
Who Can Participate
Age: 18Years - 40Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Ovary-bearing individuals aged 18 to 40 years
- Body mass index (BMI) less than 40 kg/m2
- Non-smoker for at least 3 months before enrolling
You will not qualify if you...
- Body mass index (BMI) of 40 kg/m2 or higher
- Current smoker
- Any medical contraindications to ovarian stimulation or outpatient egg retrieval under anesthesia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - 2 months or immediate
Participants either pause combined hormonal contraceptives for 2 months before planned oocyte cryopreservation or immediately begin planned oocyte cryopreservation after discontinuing contraceptives.
1 to 2 visits depending on group assignment
Trial Site Locations
Total: 3 locations
1
Yale Fertility Center
Orange, Connecticut, United States, 06477
Actively Recruiting
2
Shady Grove Fertility Rockville
Rockville, Maryland, United States, 20850
Actively Recruiting
3
Reproductive Medicine Associates of New York
New York, New York, United States, 10022
Not Yet Recruiting
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Research Team
T
Tasha Newsome, Clinical Research Supervisor
S
Seth J Barishansky, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Pituitary response to LHRH stimulation in women on oral contraceptives: a followup dose response study.
L S Wan, M Ganguly, G Weiss
https://pubmed.ncbi.nlm.nih.gov/6796328Effect 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.
Ernest Hung Yu Ng, Carina Chi Wai Chan, Oi Shan Tang...
https://pubmed.ncbi.nlm.nih.gov/15358718Impact of pituitary suppression on antral follicle count and oocyte recovery after ovarian stimulation.
Nam D Tran, Lusine Aghajanova, Chia-Ning Kao...
https://pubmed.ncbi.nlm.nih.gov/26696299Pituitary and ovarian function in women receiving hormonal contraception.
B L Cohen, M Katz
https://pubmed.ncbi.nlm.nih.gov/393456Current Contraceptive Status Among Women Aged 15-49: United States, 2017-2019.
Kimberly Daniels, Joyce C Abma
https://pubmed.ncbi.nlm.nih.gov/33151146Cryopreservation of Oocytes. Author replies.
Glenn L Schattman
https://pubmed.ncbi.nlm.nih.gov/26789885Successful 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.
Joseph O Doyle, Kevin S Richter, Joshua Lim...
https://pubmed.ncbi.nlm.nih.gov/26604065Age-specific probability of live birth with oocyte cryopreservation: an individual patient data meta-analysis.
Aylin Pelin Cil, Heejung Bang, Kutluk Oktay
https://pubmed.ncbi.nlm.nih.gov/23706339Optimal timing for elective egg freezing.
Tolga B Mesen, Jennifer E Mersereau, Jennifer B Kane...
https://pubmed.ncbi.nlm.nih.gov/25881876