Fertility PreservationHOLIDAYNCT07225660
Hormonal Optimization: Late vs. Immediate Start After Discontinuation of Oral Contraceptives in Assisted Reproductive technologY (HOLIDAY)
A study testing OCP pause in people with Fertility Preservation, run by Shady Grove Fertility Reproductive Science Center at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Fertility Preservation
- What is being tested?
- OCP pause
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 394 participants
- Where
- 3 sitesUnited States
- Study dates
- 25 Feb 2026to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Ovary-bearing individuals 18 to 40 years of age.
- BMI < 40 kg/m2
- Non-smoker for at least 3 months prior to study enrollment.
Who cannot join
- BMI greater than or equal to 40 kg/m2
- Current Smoker
- Any contraindications to ovarian stimulation or outpatient egg retrieval under anesthesia
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Not yet recruiting
Reproductive Medicine Associates of New York
New York, New York, 10022
Miriam Andrusier, MD, 212-756-5777 ext 88270, HolidayStudy@USFertility.com
- Recruiting
Yale Fertility Center
Orange, Connecticut, 06477
Seth J Barishansky, MD, 475-267-9469, HolidayStudy@USFertility.com
- Recruiting
Shady Grove Fertility Rockville
Rockville, Maryland, 20850
Tasha Newsome, 301-545-1289, 301-545-1289, Tasha.Newsome@sgfertility.com
Amalia Namath, MD, HolidayStudy@USFertility.com
About this study
Official title: A Randomized Blinded Controlled Trial Assessing Hormonal Optimization: Late vs. Immediate Start After Discontinuation of Oral Contraceptives in Assisted Reproductive technologY (HOLIDAY)
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).
Read the detailed description
Reproductive aging in women is a continuous process that begins prior to birth and extends until menopause. The primary mechanism behind this process is the depletion of the ovarian pool of non-growing follicles (NGFs). Previous models, such as the biphasic-exponential model, have postulated that female fertility prominently declines with age, significantly after age 32, and with a more accelerated rate after age 35. Newer models of ovarian follicular depletion predict no sudden change in decay rate but rather a constantly, increasing rate.
With the advent of vitrification, oocyte cryopreservation has become a powerful tool to help preserve female fertility potential against anticipated gamete exhaustion. At the same time, as more women choose to delay childbearing for various reasons, planned oocyte preservation is increasing in popularity. Continued optimization of protocols has led to improved outcomes with good oocyte yields. For women undergoing oocyte cryopreservation who are not actively attempting to conceive, endometrial development does not need to be synchronized with the oocytes. Thus, ovarian stimulation can be initiated irrespective of the phase of the menstrual cycle without adversely impacting oocyte yield or quality, thereby facilitating scheduling and reducing delays.
Many patients are utilizing combined hormonal contraception (CHC) at the time of their initial oocyte cryopreservation consultation. In the United States, about 14% of women aged 15-49 were using oral contraceptive pills (OCPs) in 2017-2019. While a short course of CHC exposure is unlikely to be detrimental to oocyte yield, longer-term CHC use may lead to significant suppression of the hypothalamic-pituitary-ovarian axis, gonadotropins, and in turn, follicular development. After only 3 months of CHC use, studies have demonstrated that the pituitary response to gonadotropin-releasing hormone is blunted. If hypothalamic-pituitary suppression from CHC prevents progression of follicle development to the antral stage, prolonged use may also lower the number of follicles susceptible to exogenous gonadotropin stimulation for oocyte collection and therefore total oocyte yield. Patients may require additional cycles and incur additional expense to achieve the desired number of cryopreserved oocytes.
It has been well demonstrated that markers of ORT, specifically, antral follicle count (AFC) and Anti-Müllerian hormone (AMH) are good predictors of oocyte yield. Existing evidence suggests that CHC use can suppress and diminish these measures of ovarian reserve by 20-30% via suppression of follicle-stimulating hormone (FSH). One study found that that long-term CHC user could increase AMH by 53% and AFC by 41%, with values returning to normal within 2 months and a plateau effect thereafter. Similarly, another study found after stopping long-term CHC use for 2 months, there was an average increase in AFC of 4.
Overall, existing literature regarding the association between hormonal contraceptive use and AMH concentration has historically been inconsistent but more recent data with large sample sizes, including a systematic review, concluded that AMH levels in women using CHC more than 6 months appears to markedly decline with recovery after discontinuation. Reproductive-age women with lower AMH percentiles at baseline may experience a greater suppressive effect from prolonged CHC use, while it is speculated that those with higher AMH percentiles at baseline may experience a lesser suppressive effect.
There are abundant observational data suggesting long-term CHC use is associated with reversable suppression of ovarian reserve markers, with biologic plausibility that this in turn may mask the "true biological potential" of the ovaries and possibly result in suboptimal oocyte yield. However, to date there are no published adequately powered prospective randomized data evaluating whether a contraceptive pause would lead to improved outcomes. Such practices may already be taking place in ART centers. The simple act of waiting for the potential of more oocytes takes on an obvious, low-risk appeal. Therefore, the investigators propose this assessor-blind, randomized clinical trial comparing a 2-month contraceptive pause to immediate oocyte cryopreservation, with oocyte yield as the primary outcome.
- Conditions
- Fertility Preservation
- Being tested
- OCP pause
- Keywords
- planned oocyte cryopreservation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCP pauseOther
Subjects in the study arm will be asked to discontinue combined hormonal contraceptives (CHC) for 2 months prior to planned oocyte cryopreservation
| Study group | Role | What they receive |
|---|---|---|
| Holiday | Other | Patients will undergo a 2 month drug holiday (pause) with combined hormonal contraceptives prior to planned oocyte cryopreservation Receives: Other: OCP pause |
| Immediate Start | No intervention | Patients will immediately begin planned oocyte cryopreservation after discontinuation of prolonged combined hormonal contraceptive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oocyte maturation rate
Median number of percentage of vitrified MII oocytes yielded per cycle
Measured: During oocyte retrieval
Number of oocytes retrieved
The median number of cumulus-oocyte complexes (COC) retrieved during oocyte retrieval
Measured: During oocyte retrieval
Secondary outcomes (1)
AMH levels
Differences in AMH levels from baseline to cycle start
Measured: AMH level differences from baseline to post-drug holiday (2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2025
- Study start25 Feb 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Fertility PreservationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 394 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shady Grove Fertility Reproductive Science Center
- Sponsor type
- University, hospital or other
- Collaborators
- EMD Serono
- Responsible party
- Principal investigator, Kate Devine, Shady Grove Fertility Reproductive Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07225660
- Sponsor's protocol ID
- Pro00090115
- Acronym
- HOLIDAY
- Status last verified
- Feb 2026
- First submitted
- 4 Nov 2025
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 6794980Wan 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.
PubMed 6796328Yu 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.
PubMed 15358718Tran 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.
PubMed 26696299Cohen 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.
PubMed 393456Daniels K, Abma JC. Current Contraceptive Status Among Women Aged 15-49: United States, 2017-2019. NCHS Data Brief. 2020 Oct;(388):1-8.
PubMed 33151146Schattman GL. Cryopreservation of Oocytes. Author replies. N Engl J Med. 2016 Jan 21;374(3):288. doi: 10.1056/NEJMc1515128. No abstract available.
PubMed 26789885Doyle 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.
PubMed 26604065Cil 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.
PubMed 23706339Mesen 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.
PubMed 25881876Rudick 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.
PubMed 20723535Noyes 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.
PubMed 19490780Hansen 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.
PubMed 18192670Sozou 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.
PubMed 23056338Dunson 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.
PubMed 14704244
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Blinded Controlled Trial Assessing Hormonal Optimization: Late vs. Immediate Start After Discontinuation of Oral Contraceptives in Assisted Reproductive technologY (HOLIDAY)
- ClinicalTrials.gov ID
- NCT07225660
- Acronym / sponsor ID
- HOLIDAY / Pro00090115
- Conditions
- Fertility Preservation
- Keywords
- planned oocyte cryopreservation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 394 participants (estimated)
- Lead sponsor
- Shady Grove Fertility Reproductive Science CenterUniversity, hospital or other
- Collaborators
- EMD Serono
- Study start
- 25 Feb 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 10 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Reproductive aging in women is a continuous process that begins prior to birth and extends until menopause. The primary mechanism behind this process is the depletion of the ovarian pool of non-growing follicles (NGFs). Previous models, such as the biphasic-exponential model, have postulated that female fertility prominently declines with age, significantly after age 32, and with a more accelerated rate after age 35. Newer models of ovarian follicular depletion predict no sudden change in decay rate but rather a constantly, increasing rate.
With the advent of vitrification, oocyte cryopreservation has become a powerful tool to help preserve female fertility potential against anticipated gamete exhaustion. At the same time, as more women choose to delay childbearing for various reasons, planned oocyte preservation is increasing in popularity. Continued optimization of protocols has led to improved outcomes with good oocyte yields. For women undergoing oocyte cryopreservation who are not actively attempting to conceive, endometrial development does not need to be synchronized with the oocytes. Thus, ovarian stimulation can be initiated irrespective of the phase of the menstrual cycle without adversely impacting oocyte yield or quality, thereby facilitating scheduling and reducing delays.
Many patients are utilizing combined hormonal contraception (CHC) at the time of their initial oocyte cryopreservation consultation. In the United States, about 14% of women aged 15-49 were using oral contraceptive pills (OCPs) in 2017-2019. While a short course of CHC exposure is unlikely to be detrimental to oocyte yield, longer-term CHC use may lead to significant suppression of the hypothalamic-pituitary-ovarian axis, gonadotropins, and in turn, follicular development. After only 3 months of CHC use, studies have demonstrated that the pituitary response to gonadotropin-releasing hormone is blunted. If hypothalamic-pituitary suppression from CHC prevents progression of follicle development to the antral stage, prolonged use may also lower the number of follicles susceptible to exogenous gonadotropin stimulation for oocyte collection and therefore total oocyte yield. Patients may require additional cycles and incur additional expense to achieve the desired number of cryopreserved oocytes.
It has been well demonstrated that markers of ORT, specifically, antral follicle count (AFC) and Anti-Müllerian hormone (AMH) are good predictors of oocyte yield. Existing evidence suggests that CHC use can suppress and diminish these measures of ovarian reserve by 20-30% via suppression of follicle-stimulating hormone (FSH). One study found that that long-term CHC user could increase AMH by 53% and AFC by 41%, with values returning to normal within 2 months and a plateau effect thereafter. Similarly, another study found after stopping long-term CHC use for 2 months, there was an average increase in AFC of 4.
Overall, existing literature regarding the association between hormonal contraceptive use and AMH concentration has historically been inconsistent but more recent data with large sample sizes, including a systematic review, concluded that AMH levels in women using CHC more than 6 months appears to markedly decline with recovery after discontinuation. Reproductive-age women with lower AMH percentiles at baseline may experience a greater suppressive effect from prolonged CHC use, while it is speculated that those with higher AMH percentiles at baseline may experience a lesser suppressive effect.
There are abundant observational data suggesting long-term CHC use is associated with reversable suppression of ovarian reserve markers, with biologic plausibility that this in turn may mask the "true biological potential" of the ovaries and possibly result in suboptimal oocyte yield. However, to date there are no published adequately powered prospective randomized data evaluating whether a contraceptive pause would lead to improved outcomes. Such practices may already be taking place in ART centers. The simple act of waiting for the potential of more oocytes takes on an obvious, low-risk appeal. Therefore, the investigators propose this assessor-blind, randomized clinical trial comparing a 2-month contraceptive pause to immediate oocyte cryopreservation, with oocyte yield as the primary outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Holiday | Other | Other: OCP pausePatients will undergo a 2 month drug holiday (pause) with combined hormonal contraceptives prior to planned oocyte cryopreservation |
| Immediate Start | No intervention | –Patients will immediately begin planned oocyte cryopreservation after discontinuation of prolonged combined hormonal contraceptive |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Ovary-bearing individuals 18 to 40 years of age.
- BMI < 40 kg/m2
- Non-smoker for at least 3 months prior to study enrollment.
Key exclusion criteria (3 listed)
- BMI greater than or equal to 40 kg/m2
- Current Smoker
- Any contraindications to ovarian stimulation or outpatient egg retrieval under anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCP pauseSubjects in the study arm will be asked to discontinue combined hormonal contraceptives (CHC) for 2 months prior to planned oocyte cryopreservation | Other | Holiday |
Primary outcome
Oocyte maturation rate
Time frame: During oocyte retrieval
Median number of percentage of vitrified MII oocytes yielded per cycle
Number of oocytes retrieved
Time frame: During oocyte retrieval
The median number of cumulus-oocyte complexes (COC) retrieved during oocyte retrieval
1 secondary outcome
AMH levels
Time frame: AMH level differences from baseline to post-drug holiday (2 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Background: PubMed 6794980Cohen 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.
- Background: PubMed 6796328Wan 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.
- Background: PubMed 15358718Yu 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.
- Background: PubMed 26696299Tran 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.
- Background: PubMed 393456Cohen 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.
- Background: PubMed 33151146Daniels K, Abma JC. Current Contraceptive Status Among Women Aged 15-49: United States, 2017-2019. NCHS Data Brief. 2020 Oct;(388):1-8.
- Background: PubMed 26789885Schattman GL. Cryopreservation of Oocytes. Author replies. N Engl J Med. 2016 Jan 21;374(3):288. doi: 10.1056/NEJMc1515128. No abstract available.
- Background: PubMed 26604065Doyle 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.
- Background: PubMed 23706339Cil 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.
- Background: PubMed 25881876Mesen 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.
- Background: PubMed 20723535Rudick 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.
- Background: PubMed 19490780Noyes 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OCP pause in people with Fertility Preservation, run by Shady Grove Fertility Reproductive Science Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tasha Newsome, Clinical Research Supervisor (301-545-1289, Tasha.Newsome@sgfertility.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oocyte maturation rate (time frame: During oocyte retrieval). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07225660, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.