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Identifying Factors Contributing to Variability in the Ovarian Response to Follicle Stimulating Drugs among Women Undergoing In-Vitro Fertilisation (IVF)

Identifying Patient and Pharmacological Factors Contributing to Variability in the Ovarian Response to FSH Stimulating Drugs among Women Undergoing In-Vitro Fertilisation (IVF)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12625000453482
Enrollment
37
Registered
2025-05-14
Start date
2025-02-21
Completion date
2025-08-11
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of the project is to understand the factors that influence how a woman undergoing IVF responds to follicle stimulating drugs. We know that the response to follicle stimulating drugs varies between women, and this impacts the number of eggs (oocytes) retrieved and resulting chance of a successful pregnancy. Using the data from this project, we hope to be able to better understand how a woman will respond to follicle stimulating drugs. This information will help us personalise treatment for IVF patients.

Interventions

Women undergoing controlled ovarian hyperstimulation for in vitro fertilisation will be prescribed follitropin alfa by their prescribing clinician. Follitropin alfa is a commonly prescribed IVF medication, and will be offered to IVF patients regardless of study involvement, unless another gonadotrophin (such as follitropin beta) is preferred by the prescriber. The dose of follitropin alfa will be at the discretion of the clinician (independent from the study) and is not standardised, however a o

Women undergoing controlled ovarian hyperstimulation for in vitro fertilisation will be prescribed follitropin alfa by their prescribing clinician. Follitropin alfa is a commonly prescribed IVF medication, and will be offered to IVF patients regardless of study involvement, unless another gonadotrophin (such as follitropin beta) is preferred by the prescriber. The dose of follitropin alfa will be at the discretion of the clinician (independent from the study) and is not standardised, however a once daily administration is common. Dosing information will be collected by the study investigators. Standard Care Participation: As part of routine IVF care, blood samples are collected for each participant's fertility treatment. At the same time that these samples are drawn, an additional sample will be collected for research purposes, including genetic analysis. These samples will be collected on: the day of starting follitropin alfa, five days after starting follitropin alfa, and the day of ovum pick up. Total number of blood samples: 3 Enhanced Participation: Participants are invited to opt into an enhanced level of participation, where they undergo two additional blood samples (as well as the blood samples taken in line with Standard Care Participation). Enhanced participation is offered to all participants, until the allocated sample size is reached (N=50). The first additional sample will be between five days after starting follitropin alfa and the day prior to administering the ovulation trigger shot. The second additional sample will be on the day of the ovulation trigger shot. Total number of blood samples: 5

Sponsors

Monash University
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
18 Years to 46 Years
Healthy volunteers
No

Inclusion criteria

Willingness to provide written informed consent as part of study participation Proficient in the English language Currently receiving treatment at participating sites Prescribed follitropin alfa for controlled ovarian stimulation, at any dose, prior to treatment initiation Any cycle of IVF ± intracytoplasmic sperm injection (ICSI) Participants are eligible for recruitment for multiple cycles until a successful pregnancy outcome Aged between 18 and 46 years old BMI less than 35 kg/m2 Participants undergoing ovarian stimulation for elective fertility preservation

Exclusion criteria

Unable to provide written informed consent Morphologically abnormal or absent ovary Women with known endocrine, genetic, systematic inflammatory-immunological disorders Women with hypothalamic dysfunction, history of endometriosis with ovarian surgery, history of ovarian surgery, or a history of pelvic radiotherapy and/or chemotherapy

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026