Use of Clomiphene Citrate as an Inhibitor of Ovulation in an Oocyte Cryopreservation Cycle
CCOI
1 other identifier
observational
10
1 country
1
Brief Summary
In vitro fertilization (IVF) has helped countless couples conceive where they otherwise were unable, but does come at a significant cost. A large portion of that cost is in the medications that allow for controlled ovarian hyperstimulation. One aspect of treatment is in ovulation inhibition to allow for supraphysiologic recruitment of oocytes prior to natural ovulation. Historically, GnRH agonist and antagonists have been used. However, these are subcutaneous injections and can be costly. Clomiphene citrate is a selective estrogen receptor modulator that acts as an estrogen antagonist in the hypothalamus and pituitary and is an inexpensive oral agent. It may be used as an inhibitor of ovulation in IVF in theory but this has never been attempted to the best of our knowledge.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2023
CompletedFirst Posted
Study publicly available on registry
May 19, 2023
CompletedStudy Start
First participant enrolled
July 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2024
CompletedMay 19, 2023
May 1, 2023
1 year
May 9, 2023
May 17, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Ovulation
Evidence of premature ovulation during IVF stimulation
3 weeks
Secondary Outcomes (3)
Oocyte yield
3 weeks
Maturity Rate
3 weeks
Side effects
3 weeks
Interventions
Eligibility Criteria
Patients who are interested in elective oocyte cryopreservation as a pilot group to investigate the feasibility of using clomiphene as an ovulation inhibitor.
You may qualify if:
- Female
- years old, inclusive
- Planning to undergo IVF with egg retrieval for oocyte cryopreservation
You may not qualify if:
- Tobacco or illicit drug use
- History of infertility
- Prior failed IVF or OC cycle
- Drug allergy to Clomid
- Hypertension
- Migraine with aura
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Neil Chappelllead
Study Sites (1)
Womans Hospital
Baton Rouge, Louisiana, 70817, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Physician
Study Record Dates
First Submitted
May 9, 2023
First Posted
May 19, 2023
Study Start
July 1, 2023
Primary Completion
June 30, 2024
Study Completion
October 31, 2024
Last Updated
May 19, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share