InfertilityNCT00646568
Human Chorionic Gonadotropin (hCG) Test: A Novel Method to Evaluate the Ovarian Reserve
A study testing s.c. human chorionic gonadotropin (Pregnyl) in people with Infertility, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
In an era of delayed fertility plans, there is an increasing need for a reliable method to predict ovarian reserve and responsiveness. The current tests include serum FSH, Inhibin B, Mullerian inhibiting factor (MIF) and ultrasonographic measures such as ovarian volume and number of antral follicles are non-specific… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- s.c. human chorionic gonadotropin (Pregnyl)
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2008to Jan 2010
- Phase
- Interventional
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All women on IVF cycle
Who cannot join
- Any allergy to injection of human chorionic gonadotropin before
Trial locations and contacts
1 site in 1 country.
About this study
Official title: hCG Stimulating Test of the Thecal Cells to Evaluate the Ovarian Reserve
In an era of delayed fertility plans, there is an increasing need for a reliable method to predict ovarian reserve and responsiveness. The current tests include serum FSH, Inhibin B, Mullerian inhibiting factor (MIF) and ultrasonographic measures such as ovarian volume and number of antral follicles are non-specific and with questionable reliability. The biochemical tests represent the function of production of androgens, as a predictor of ovarian reserve, has not been tested yet.
Working hypothesis and aims: testing the prognostic capability of hCG stimulating test of theca cells for estimating the ovarian reserve, and by that to calculate better the chance for IVF cycle success
Read the detailed description
20 women >40 years old and 20 women <35 years old, attended to our IVF unit were included in the study. Another 20 other young women (<35 years) with poor response in previous IVF cycles will be participate. All participants received a single hCG 10000 IU injection on cycle day 2-4. Hormone levels of LH, FSH, E2, P, Testosterone, Androstendione and 17-OHP were taken prior to the injection and on days 1, 3 and 7 afterwards. hCG induced hormone levels will be compared with IVF results
- Conditions
- Infertility
- Being tested
- s.c. human chorionic gonadotropin (Pregnyl)
- Keywords
- IVF, ovarian reserve, androgens, thecal cells, Fertility Agents, Female
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
s.c. human chorionic gonadotropin (Pregnyl)Drug
S.C. Pregnyl 10000 IU once
What is being measured
The primary outcome is the main question the study is designed to answer.
androgens levels after stimulation in relation to the ovarian reserve
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2008 (estimated)
- Study startJun 2008
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Assaf Ben-Meir, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00646568
- Sponsor's protocol ID
- hcgstimtest-HMO-CTIL
- Status last verified
- Jun 2011
- First submitted
- 17 Mar 2008
- Last updated
- 23 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- hCG Stimulating Test of the Thecal Cells to Evaluate the Ovarian Reserve
- ClinicalTrials.gov ID
- NCT00646568
- Acronym / sponsor ID
- hcgstimtest-HMO-CTIL
- Conditions
- Infertility
- Keywords
- IVF, ovarian reserve, androgens, thecal cells, Fertility Agents, Female
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 28 Mar 2008 (estimated)
- 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 an era of delayed fertility plans, there is an increasing need for a reliable method to predict ovarian reserve and responsiveness. The current tests include serum FSH, Inhibin B, Mullerian inhibiting factor (MIF) and ultrasonographic measures such as ovarian volume and number of antral follicles are non-specific and with questionable reliability. The biochemical tests represent the function of production of androgens, as a predictor of ovarian reserve, has not been tested yet.
Working hypothesis and aims: testing the prognostic capability of hCG stimulating test of theca cells for estimating the ovarian reserve, and by that to calculate better the chance for IVF cycle success
Detailed description
20 women >40 years old and 20 women <35 years old, attended to our IVF unit were included in the study. Another 20 other young women (<35 years) with poor response in previous IVF cycles will be participate. All participants received a single hCG 10000 IU injection on cycle day 2-4. Hormone levels of LH, FSH, E2, P, Testosterone, Androstendione and 17-OHP were taken prior to the injection and on days 1, 3 and 7 afterwards. hCG induced hormone levels will be compared with IVF results
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All women on IVF cycle
Key exclusion criteria (1 listed)
- Any allergy to injection of human chorionic gonadotropin before
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 |
|---|---|---|
| s.c. human chorionic gonadotropin (Pregnyl)S.C. Pregnyl 10000 IU once | Drug | – |
Primary outcome
androgens levels after stimulation in relation to the ovarian reserve
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
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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.
Assaf Ben-Meir, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing s.c. human chorionic gonadotropin (Pregnyl) in people with Infertility, run by Hadassah Medical Organization at 1 site in Israel.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 23 Jun 2011. 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 Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
androgens levels after stimulation in relation to the ovarian reserve (time frame: 2 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 23 Jun 2011.