Female Subjects Undergoing Controlled Ovarian HyperstimulationNCT07460674
Serum FSH Levels During Controlled Ovarian Stimulation
An observational study of Female Subjects Undergoing Controlled Ovarian Hyperstimulation, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
Follicle-stimulating hormone (FSH) plays a central role in controlled ovarian stimulation (COS) during in vitro fertilization (IVF) cycles. While baseline FSH is commonly used to assess ovarian reserve, the clinical significance of dynamic FSH changes during stimulation remains unclear. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Female Subjects Undergoing Controlled Ovarian Hyperstimulation
- How many people
- 500 participants
- Where
- 1 siteCanada
- Study dates
- 16 Feb 2026to Dec 2030
- Phase
- Observational
- 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 44 years
- Women only
- No healthy volunteers
- Adult
Study population: Study will include patients undergoing controlled ovarian stimulation at the MUHC Reproductive Center. Nursing and medical team will recruit patients on their initial visit when they get their treatment plan and prescription at the MUHC Reproductive Center.
Who may be able to join
- Patients undergoing controlled ovarian stimulation
- All stimulation protocols (agonist and antagonist).
- All gonadotropin formulation (Gonal-F, Menopur, Rekovelle, Puregon).
Who cannot join
- Cancer fertility preservation patients .
- Patients over age 44.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Follicle-stimulating hormone (FSH) plays a central role in controlled ovarian stimulation (COS) during in vitro fertilization (IVF) cycles. While baseline FSH is commonly used to assess ovarian reserve, the clinical significance of dynamic FSH changes during stimulation remains unclear. Limited evidence suggests that serum FSH levels during COS may reflect ovarian response and could be associated with follicular development and treatment outcomes, yet FSH is not routinely monitored throughout stimulation protocols.
This prospective single-center cohort study aims to evaluate the dynamics of serum FSH levels during COS and to examine their association with ovarian response and IVF outcomes. Serum FSH, luteinizing hormone (LH) and estradiol (E2) will be measured at predefined time points during stimulation. Associations between FSH levels and oocyte yield, embryo development, and pregnancy outcomes will be analyzed to better understand the clinical relevance of FSH monitoring during IVF treatment.
Read the detailed description
Background and Rationale
Follicle-stimulating hormone (FSH), secreted by the anterior pituitary gland in response to gonadotropin-releasing hormone (GnRH), plays a critical role in ovarian follicular development and estradiol production. In assisted reproductive technologies (ART), exogenous FSH is administered during controlled ovarian stimulation (COS) to promote multifollicular growth. Although baseline FSH is widely used as a marker of ovarian reserve and predictor of ovarian response, the clinical significance of dynamic FSH changes during stimulation remains insufficiently characterized.
Day 7 of stimulation represents a clinically important time point during which follicular growth and synchronization are assessed. Prior studies have suggested that serum FSH levels during COS may correlate with ovarian response and may reflect an individualized FSH threshold beyond which increasing exogenous dosing may not improve follicular recruitment. However, consensus is lacking regarding the clinical utility of serial FSH monitoring during stimulation, and it is not routinely incorporated into IVF protocols.
Understanding the relationship between FSH dynamics, follicular development, estradiol production, and treatment outcomes may support more individualized stimulation strategies and improve reproductive outcomes.
Study Design
This is a prospective observational cohort study conducted at a single academic fertility center at the McGill University Health Centre (MUHC) Reproductive Centre.
Study Population
Eligible participants include patients undergoing controlled ovarian stimulation for IVF or ICSI at the MUHC Reproductive Centre. All stimulation protocols (GnRH agonist and antagonist) and all gonadotropin formulations (including Gonal-F, Menopur, Rekovelle, and Puregon) are included.
Data Collection
Demographic and clinical data will include age, body mass index (BMI), obstetric history, indication for treatment, and stimulation protocol details.
Serum hormone levels of will be measured at three predefined time points:
- Baseline (cycle day 3)
- Day 7 or 8 of gonadotropin stimulation
- Trigger day (day of trigger shot before oocyte retrieval)
Blood samples will be collected at time points that coincide with routine visits for women undergoing ovarian stimulation, during which blood tests are already performed as part of standard clinical care
The hormones measured include:
Serum Follicle-stimulating hormone (FSH) (mIU/mL) Luteinizing hormone (LH) (mIU/mL) Estradiol (E2) (pmol/L) Anti-Müllerian Hormone (AMH) (ng/mL)
- Keywords
- IVF, Controlled ovarian hyperstimulation, FSH, Infertiltiy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Stimulation patients | Patients undergoing controlled ovarian stimulation at the MUHC Reproductive Center. |
What is being measured
The primary outcome is the main question the study is designed to answer.
-Trigger day FSH levels
Serum Follicle-stimulating hormone (FSH) (mIU/mL) measured at the day of the trigger shot
Measured: 60 months
Trigger day E2 levels
Serum Estradiol (E2) (pg/mL) levels measured at trigger shot day
Measured: 60 months
Number of patients reaching trigger
The number of patients that received the trigger shot and proceeding to oocyte retrieval / The number pf patients canceled during the ovarian stimulation
Measured: 60 months
Number of oocytes retrieved
The number of oocytes collected in the oocyte retrieval procedure
Measured: 60 months
Number of transferable embryos
Number of embryos were transferred in the fresh cycle plus the number of frozen embryos
Measured: 60 months
Secondary outcomes (3)
Biochemical pregnancy rate
Positive pregnancy test (i.e positive serum HCG level >20 U/L after 11 days of ET of D5 embryo and 13 after D3 embryo transfer) per transfer
Measured: 60 months
Clinical pregnancy rate
Pregnancy diagnosed by ultrasound with at least one embryo and a discernable heartbeat per transfer
Measured: 60 months
Miscarriage rate
Spontaneous loss of clinical pregnancy before 12 weeks per transfer
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start16 Feb 2026 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Female Subjects Undergoing Controlled Ovarian HyperstimulationStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Dahan, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07460674
- Sponsor's protocol ID
- 2026-11743
- Status last verified
- Mar 2026
- First submitted
- 13 Feb 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sun PP, Zhang YM, Zhu HY, Sun N, Ma HG. The relationship between serum FSH level and ovarian response during controlled ovarian stimulation. Ginekol Pol. 2023;94(6):470-475. doi: 10.5603/GP.a2022.0010. Epub 2022 Apr 14.
PubMed 35419793de Koning CH, Schoemaker J, Lambalk CB. Estimation of the follicle-stimulating hormone (FSH) threshold for initiating the final stages of follicular development in women with elevated FSH levels in the early follicular phase. Fertil Steril. 2004 Sep;82(3):650-3. doi: 10.1016/j.fertnstert.2004.01.043.
PubMed 15374709Bentov Y, Burstein E, Firestone C, Firestone R, Esfandiari N, Casper RF. Can cycle day 7 FSH concentration during controlled ovarian stimulation be used to guide FSH dosing for in vitro fertilization? Reprod Biol Endocrinol. 2013 Feb 22;11:12. doi: 10.1186/1477-7827-11-12.
PubMed 23433095Abdalla H, Thum MY. An elevated basal FSH reflects a quantitative rather than qualitative decline of the ovarian reserve. Hum Reprod. 2004 Apr;19(4):893-8. doi: 10.1093/humrep/deh141. Epub 2004 Mar 11.
PubMed 15016786
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum FSH Levels During Controlled Ovarian Stimulation
- ClinicalTrials.gov ID
- NCT07460674
- Acronym / sponsor ID
- 2026-11743
- Keywords
- IVF, Controlled ovarian hyperstimulation, FSH, Infertiltiy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 16 Feb 2026 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 10 Mar 2026 (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.
Follicle-stimulating hormone (FSH) plays a central role in controlled ovarian stimulation (COS) during in vitro fertilization (IVF) cycles. While baseline FSH is commonly used to assess ovarian reserve, the clinical significance of dynamic FSH changes during stimulation remains unclear. Limited evidence suggests that serum FSH levels during COS may reflect ovarian response and could be associated with follicular development and treatment outcomes, yet FSH is not routinely monitored throughout stimulation protocols.
This prospective single-center cohort study aims to evaluate the dynamics of serum FSH levels during COS and to examine their association with ovarian response and IVF outcomes. Serum FSH, luteinizing hormone (LH) and estradiol (E2) will be measured at predefined time points during stimulation. Associations between FSH levels and oocyte yield, embryo development, and pregnancy outcomes will be analyzed to better understand the clinical relevance of FSH monitoring during IVF treatment.
Detailed description
Background and Rationale
Follicle-stimulating hormone (FSH), secreted by the anterior pituitary gland in response to gonadotropin-releasing hormone (GnRH), plays a critical role in ovarian follicular development and estradiol production. In assisted reproductive technologies (ART), exogenous FSH is administered during controlled ovarian stimulation (COS) to promote multifollicular growth. Although baseline FSH is widely used as a marker of ovarian reserve and predictor of ovarian response, the clinical significance of dynamic FSH changes during stimulation remains insufficiently characterized.
Day 7 of stimulation represents a clinically important time point during which follicular growth and synchronization are assessed. Prior studies have suggested that serum FSH levels during COS may correlate with ovarian response and may reflect an individualized FSH threshold beyond which increasing exogenous dosing may not improve follicular recruitment. However, consensus is lacking regarding the clinical utility of serial FSH monitoring during stimulation, and it is not routinely incorporated into IVF protocols.
Understanding the relationship between FSH dynamics, follicular development, estradiol production, and treatment outcomes may support more individualized stimulation strategies and improve reproductive outcomes.
Study Design
This is a prospective observational cohort study conducted at a single academic fertility center at the McGill University Health Centre (MUHC) Reproductive Centre.
Study Population
Eligible participants include patients undergoing controlled ovarian stimulation for IVF or ICSI at the MUHC Reproductive Centre. All stimulation protocols (GnRH agonist and antagonist) and all gonadotropin formulations (including Gonal-F, Menopur, Rekovelle, and Puregon) are included.
Data Collection
Demographic and clinical data will include age, body mass index (BMI), obstetric history, indication for treatment, and stimulation protocol details.
Serum hormone levels of will be measured at three predefined time points:
- Baseline (cycle day 3)
- Day 7 or 8 of gonadotropin stimulation
- Trigger day (day of trigger shot before oocyte retrieval)
Blood samples will be collected at time points that coincide with routine visits for women undergoing ovarian stimulation, during which blood tests are already performed as part of standard clinical care
The hormones measured include:
Serum Follicle-stimulating hormone (FSH) (mIU/mL) Luteinizing hormone (LH) (mIU/mL) Estradiol (E2) (pmol/L) Anti-Müllerian Hormone (AMH) (ng/mL)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stimulation patients | – | –Patients undergoing controlled ovarian stimulation at the MUHC Reproductive Center. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Study will include patients undergoing controlled ovarian stimulation at the MUHC Reproductive Center. Nursing and medical team will recruit patients on their initial visit when they get their treatment plan and prescription at the MUHC Reproductive Center.
Key inclusion criteria (3 listed)
- Patients undergoing controlled ovarian stimulation
- All stimulation protocols (agonist and antagonist).
- All gonadotropin formulation (Gonal-F, Menopur, Rekovelle, Puregon).
Key exclusion criteria (2 listed)
- Cancer fertility preservation patients .
- Patients over age 44.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
-Trigger day FSH levels
Time frame: 60 months
Serum Follicle-stimulating hormone (FSH) (mIU/mL) measured at the day of the trigger shot
Trigger day E2 levels
Time frame: 60 months
Serum Estradiol (E2) (pg/mL) levels measured at trigger shot day
Number of patients reaching trigger
Time frame: 60 months
The number of patients that received the trigger shot and proceeding to oocyte retrieval / The number pf patients canceled during the ovarian stimulation
Number of oocytes retrieved
Time frame: 60 months
The number of oocytes collected in the oocyte retrieval procedure
Number of transferable embryos
Time frame: 60 months
Number of embryos were transferred in the fresh cycle plus the number of frozen embryos
3 secondary outcomes
Biochemical pregnancy rate
Time frame: 60 months
Clinical pregnancy rate
Time frame: 60 months
Miscarriage rate
Time frame: 60 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 10 Mar 2026.
- Background: PubMed 35419793Sun PP, Zhang YM, Zhu HY, Sun N, Ma HG. The relationship between serum FSH level and ovarian response during controlled ovarian stimulation. Ginekol Pol. 2023;94(6):470-475. doi: 10.5603/GP.a2022.0010. Epub 2022 Apr 14.
- Background: PubMed 15374709de Koning CH, Schoemaker J, Lambalk CB. Estimation of the follicle-stimulating hormone (FSH) threshold for initiating the final stages of follicular development in women with elevated FSH levels in the early follicular phase. Fertil Steril. 2004 Sep;82(3):650-3. doi: 10.1016/j.fertnstert.2004.01.043.
- Background: PubMed 23433095Bentov Y, Burstein E, Firestone C, Firestone R, Esfandiari N, Casper RF. Can cycle day 7 FSH concentration during controlled ovarian stimulation be used to guide FSH dosing for in vitro fertilization? Reprod Biol Endocrinol. 2013 Feb 22;11:12. doi: 10.1186/1477-7827-11-12.
- Background: PubMed 15016786Abdalla H, Thum MY. An elevated basal FSH reflects a quantitative rather than qualitative decline of the ovarian reserve. Hum Reprod. 2004 Apr;19(4):893-8. doi: 10.1093/humrep/deh141. Epub 2004 Mar 11.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Female Subjects Undergoing Controlled Ovarian Hyperstimulation, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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 2 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: opening soon, as of the sponsor's last update on 10 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 1 site in Canada. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
-Trigger day FSH levels (time frame: 60 months). The study lists 5 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 NCT07460674, which also lists 4 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 10 Mar 2026.