OCP Pause for Fertility Preservation
(HOLIDAY Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how a break from combined hormonal contraceptives (CHC) affects the process of freezing eggs (oocyte cryopreservation) for future family planning. Participants will either pause CHC for two months before starting the egg-freezing process or begin immediately after stopping CHC. The goal is to determine if taking a break impacts the success of egg preservation. Individuals with ovaries, who are non-smokers, and have a BMI under 40 may be suitable for this trial. As an unphased study, this trial offers a unique opportunity to contribute to understanding fertility preservation options.
Do I need to stop taking my current medications for this trial?
The trial involves a 2-month pause of Combined Hormonal Contraceptives (CHC) for some participants, so you may need to stop taking these specific medications.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that taking a break from birth control pills before preserving fertility does not reduce the number of mature eggs collected. Studies also indicate that using hormonal birth control for at least three months can improve the chances of getting pregnant later.
No evidence suggests that stopping or continuing birth control pills harms the number or quality of eggs. Either choice should be safe for egg health. Overall, both options are generally well-tolerated, with no major safety concerns identified in previous research.12345Why are researchers excited about this trial?
Researchers are excited about the "OCP Pause" approach to fertility preservation because it explores a unique timing strategy that could enhance outcomes. Unlike the standard practice of immediately beginning oocyte cryopreservation after stopping hormonal contraceptives, this method introduces a two-month pause. This pause might allow the body to reset hormone levels, potentially improving egg quality and increasing the success rate of preservation. By investigating this timing alteration, researchers hope to uncover new insights into optimizing fertility treatments.
What evidence suggests that the OCP pause could be effective for fertility preservation?
This trial will compare two approaches for patients planning oocyte cryopreservation: a 2-month break from combined hormonal contraceptives (CHC) versus an immediate start of oocyte cryopreservation after stopping prolonged CHC use. Research has shown that long-term CHC use can temporarily lower indicators of ovarian reserve, which reflect the number of eggs a woman currently has. This suggests that a break from CHC might improve these indicators and potentially aid in egg freezing. However, studies on various contraceptive methods have found no negative effects on the number or quality of eggs collected for freezing. While some evidence suggests a break might be beneficial, current data shows no harm in continuing CHC until egg freezing. Overall, a pause might be advantageous, but further research is needed to confirm this.12678
Are You a Good Fit for This Trial?
This trial is for individuals planning to freeze their eggs (oocyte cryopreservation) and are currently using combined hormonal contraceptives. Participants will be chosen randomly to either stop taking the contraceptive for 2 months before starting fertility treatment or begin treatment immediately after stopping.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Drug Holiday
Participants undergo a 2-month pause with combined hormonal contraceptives prior to planned oocyte cryopreservation
Immediate Start
Participants immediately begin planned oocyte cryopreservation after discontinuation of prolonged combined hormonal contraceptive
Follow-up
Participants are monitored for safety and effectiveness after oocyte retrieval
What Are the Treatments Tested in This Trial?
Interventions
- OCP pause
Trial Overview
The HOLIDAY study is testing whether a break from oral contraceptives affects egg freezing outcomes. Half of the participants will wait two months after stopping birth control before beginning fertility treatments, while the other half will start treatments right away.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Patients will undergo a 2 month drug holiday (pause) with combined hormonal contraceptives prior to planned oocyte cryopreservation
Patients will immediately begin planned oocyte cryopreservation after discontinuation of prolonged combined hormonal contraceptive
Find a Clinic Near You
Who Is Running the Clinical Trial?
Shady Grove Fertility Reproductive Science Center
Lead Sponsor
EMD Serono
Industry Sponsor
Dr. Shepard
EMD Serono
Chief Medical Officer since 2021
MD from University of Cincinnati Medical School, Fellowships in Hematology and Oncology at University of Chicago Hospitals and Clinics
Miguel Fernández Alcalde
EMD Serono
Chief Executive Officer
Bachelor's Degree in Pharmacy from the University Complutense in Madrid, MBA from the University of Alcalá de Henares, Master's Degree in Management from IESE Business School
Citations
Study Details | NCT07225660 | A Randomized Blinded ...
There are abundant observational data suggesting long-term CHC use is associated with reversable suppression of ovarian reserve markers, with ...
Article Effect of various contraceptives on oocyte yield and ...
This study evaluated POC cycle outcomes in women who used some form of contraception and found that the method of contraception was not associated with ...
effect-of-various-contraceptives-on-oocyte-yield-and- ...
Results: A total of 4059 oocyte freezing cycles were included in the analysis. Eight types of contraceptive method were recognized in patients undergoing ...
Effect of various contraceptives on oocyte yield and ...
Among the various forms of contraception, none was shown to have an adverse association with oocyte yield or maturation rate in patients undergoing POC.
5.
researchgate.net
researchgate.net/publication/382049931_Effect_of_various_contraceptives_on_oocyte_yield_and_maturation_in_patients_undergoing_planned_oocyte_cryopreservation(PDF) Effect of various contraceptives on oocyte yield and ...
Effect of various contraceptives on oocyte yield and maturation in patients undergoing planned oocyte cryopreservation ; The study cohorts were ...
The use of hormonal contraceptives in fertility treatments
They found improved implantation and clinical pregnancy rates in subjects using at least 3 months of hormonal contraception compared with those in non–oral ...
The use of hormonal contraceptives in fertility treatments
They found improved implantation and clinical pregnancy rates in subjects using at least 3 months of hormonal contraception compared with those in non–oral ...
TAKING A BREAK FROM ORAL CONTRACEPTIVE PILLS ...
PAUSING THE PILL: TAKING A BREAK FROM ORAL CONTRACEPTIVE PILLS (OCP) BEFORE FERTILITY PRESERVATION (FP) DOES NOT IMPACT THE METAPHASE II ...
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