Infertility, FemaleCCOINCT05866068
Use of Clomiphene Citrate as an Inhibitor of Ovulation in an Oocyte Cryopreservation Cycle
An observational study of Infertility, Female and Infertility, run by Neil Chappell at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Infertility, Female, Infertility
- What is being tested?
- Clomiphene
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2023to 31 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 42 years
- Women only
- Adult
Study population: Patients who are interested in elective oocyte cryopreservation as a pilot group to investigate the feasibility of using clomiphene as an ovulation inhibitor.
Who may be able to join
- Female
- 18-42 years old, inclusive
- Planning to undergo IVF with egg retrieval for oocyte cryopreservation
Who cannot join
- Tobacco or illicit drug use
- History of infertility
- Prior failed IVF or OC cycle
- Drug allergy to Clomid
- Hypertension
- Migraine with aura
Trial locations and contacts
1 site in 1 country.
United States1 site
Womans Hospital
Baton Rouge, Louisiana, 70817
Neil R Chappell, MD, MSCI, 225-926-6886, nchappell@fertilityanswers.com
About this study
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.
Read the detailed description
In vitro fertilization (IVF) has been used for over 40 years in treating infertility, and with the advent of cryopreservation, it is now possible to stimulate, retrieve and freeze oocytes for use at a later date. In fact, in late 2012 the FDA removed the experimental label from oocyte cryopreservation (OC), allowing for OC cycles to become a standard of care for patients with conditions that threaten their ovarian reserve or patients who wish to preserve their fertility electively. Currently, standard stimulation protocols for superovulation of oocytes for OC involve subcutaneous injections of GnRH agonists or antagonists to inhibit premature natural ovulation as the higher number of oocytes are recruited with gonadotropins. These medications are costly and cumbersome and therefore it is of interest to design protocols that are both easier on patient compliance and more cost effective.
Clomiphene citrate is a selective estrogen receptor modulator (SERM). It selectively binds to estrogen receptors in the hypothalamus, pituitary, ovary, endometrium, and cervix producing estrogenic and anti-estrogenic effects. However the exact mechanism of clomid is poorly understood. Multiple studies have been done through animal models. One studied showed that it inhibits the negative feedback of endogenous estrogen to subsequently increase secretion of GnRH. It is also shown to increase the frequency of GnRH, however not the amplitude [Wallach]. Current IVF protocols use either GnRH antagonist or agonist to inhibit premature ovulation. Therefore due to Clomid effect on both the hypothalamus and pituitary it could theoretically block ovulation if taken continuously to down regulate the GnRH receptors.
A study published in 1982 by Marut and Hodgen looked at the effect of high doses clomiphene in primates with normal cycles. Using high dose clomiphene (25mg daily) for five days then evaluated gonadotropins, estrogen, progesterone and preformed serial laparoscopies. In all 18 of the treatment cycles there was a delay in ovulation. Upon literature review, no other studies had been conducted looking using clomiphene citrate as a medication to inhibit ovulation during an ovarian stimulation cycle.
- Conditions
- Infertility, Female, Infertility
- Being tested
- Clomiphene
- Medical subject headings
- Infertility, Female, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClomipheneDrug
Also called Clomid
Clomiphene citrate 100mg daily during IVF stimulation
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovulation
Evidence of premature ovulation during IVF stimulation
Measured: 3 weeks
Secondary outcomes (3)
Oocyte yield
Number of oocytes from IVF cycle
Measured: 3 weeks
Maturity Rate
% of eggs mature / # of oocytes collected
Measured: 3 weeks
Side effects
Number of patients reporting side effects of medication
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start1 Jul 2023 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neil Chappell
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Neil Chappell, Woman's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866068
- Sponsor's protocol ID
- Womans
- Acronym
- CCOI
- Status last verified
- May 2023
- First submitted
- 9 May 2023
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Clomiphene Citrate as an Inhibitor of Ovulation in an Oocyte Cryopreservation Cycle
- ClinicalTrials.gov ID
- NCT05866068
- Acronym / sponsor ID
- CCOI / Womans
- Conditions
- Infertility, Female, Infertility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Neil ChappellUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 19 May 2023 (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.
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.
Detailed description
In vitro fertilization (IVF) has been used for over 40 years in treating infertility, and with the advent of cryopreservation, it is now possible to stimulate, retrieve and freeze oocytes for use at a later date. In fact, in late 2012 the FDA removed the experimental label from oocyte cryopreservation (OC), allowing for OC cycles to become a standard of care for patients with conditions that threaten their ovarian reserve or patients who wish to preserve their fertility electively. Currently, standard stimulation protocols for superovulation of oocytes for OC involve subcutaneous injections of GnRH agonists or antagonists to inhibit premature natural ovulation as the higher number of oocytes are recruited with gonadotropins. These medications are costly and cumbersome and therefore it is of interest to design protocols that are both easier on patient compliance and more cost effective.
Clomiphene citrate is a selective estrogen receptor modulator (SERM). It selectively binds to estrogen receptors in the hypothalamus, pituitary, ovary, endometrium, and cervix producing estrogenic and anti-estrogenic effects. However the exact mechanism of clomid is poorly understood. Multiple studies have been done through animal models. One studied showed that it inhibits the negative feedback of endogenous estrogen to subsequently increase secretion of GnRH. It is also shown to increase the frequency of GnRH, however not the amplitude [Wallach]. Current IVF protocols use either GnRH antagonist or agonist to inhibit premature ovulation. Therefore due to Clomid effect on both the hypothalamus and pituitary it could theoretically block ovulation if taken continuously to down regulate the GnRH receptors.
A study published in 1982 by Marut and Hodgen looked at the effect of high doses clomiphene in primates with normal cycles. Using high dose clomiphene (25mg daily) for five days then evaluated gonadotropins, estrogen, progesterone and preformed serial laparoscopies. In all 18 of the treatment cycles there was a delay in ovulation. Upon literature review, no other studies had been conducted looking using clomiphene citrate as a medication to inhibit ovulation during an ovarian stimulation cycle.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Patients who are interested in elective oocyte cryopreservation as a pilot group to investigate the feasibility of using clomiphene as an ovulation inhibitor.
Key inclusion criteria (3 listed)
- Female
- 18-42 years old, inclusive
- Planning to undergo IVF with egg retrieval for oocyte cryopreservation
Key exclusion criteria (6 listed)
- Tobacco or illicit drug use
- History of infertility
- Prior failed IVF or OC cycle
- Drug allergy to Clomid
- Hypertension
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 |
|---|---|---|
| ClomipheneAlso: ClomidClomiphene citrate 100mg daily during IVF stimulation | Drug | – |
Primary outcome
Ovulation
Time frame: 3 weeks
Evidence of premature ovulation during IVF stimulation
3 secondary outcomes
Oocyte yield
Time frame: 3 weeks
Maturity Rate
Time frame: 3 weeks
Side effects
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- 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. This study is not recruiting at the moment.
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 Infertility, Female and Infertility, run by Neil Chappell at 1 site 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 6 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: status not confirmed, as of the sponsor's last update on 19 May 2023. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ovulation (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 May 2023.