AMHNCT04512807
AMH and Pregnancy Outcome in IVF
An observational study of AMH, run by Al Baraka Fertility Hospital.
Trial summary
Anti-Mu¨llerian hormone (AMH) is an established marker of ovarian reserve (La Marca et al., 2010; Nelson et al., 2009) and predicts both high and low responses in ovarian stimulation cycles (Eldar-Geva et al., 2005; Nardo et al., 2009; Nelson et al., 2007). Read more about this study
- Who is it for?
- Ages 22 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- AMH
- What is being tested?
- AMH
- How many people
- 650 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2020to 25 Nov 2020
- 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 22 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients with low or very low AMH
Who may be able to join
- Women ≥22 years age AMH is 0.5 and less Body mass index- 18.5-30 kg/m 2 The normal uterine cavity on ultrasound scan At least one good quality embryo present for transfer Women willing to comply with the clinical study protocol
Who cannot join
- Women ≥ 45 years age
- AMH >0.5
- Uterine abnormalities that can compromise the IRs (e.g., endometrial polyp, fibroids, hydrosalpinx, and adenomyosis)
- Endocrine dysfunction or organ dysfunction such as liver or kidney failure.
About this study
Official title: Low Anti-mullerian Hormone and Pregnancy Outcome in IVF
Anti-Mu¨llerian hormone (AMH) is an established marker of ovarian reserve (La Marca et al., 2010; Nelson et al., 2009) and predicts both high and low responses in ovarian stimulation cycles (Eldar-Geva et al., 2005; Nardo et al., 2009; Nelson et al., 2007). Presently, AMH helps clinicians counsel patients prior to IVF treatment (La Marca et al., 2011), despite the fact that it fails to predict who will become pregnant (Lamazou et al., 2011; Riggs et al., 2011). It has been demonstrated that poor responders can achieve both pregnancy and live birth (Weghofer et al., 2011). There are few studies regarding extremely low AMH concentrations and live births (Fraisse et al., 2008; Tocci et al., 2009; Weghofer et al., 2011) and they present either a small number of patients or limited data describing the groups of investigated patients. Another factor affecting pregnancy rates is endometriosis, a chronic gynaecological disease characterized by the presence of functional endometrial tissue outside the uterine cavity (Koninckx et al., 1991). Many studies have reported that pregnancy rates are lower in women with endometriosis than in controls (Gupta et al., 2008; Koninckx et al., 1991 Pellicer et al., 2000). Lower AMH serum concentrations are associated with endometriosis severity (Shebl et al., 2006). The primary objective of the present study was to assess the clinical pregnancy rates in women with extremely low AMH concentrations with respect to age.
- Conditions
- AMH
- Being tested
- AMH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMHDiagnostic test
AMH \& PREGNANCY
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy test
B-HCG
Measured: 2 weeks
clinical pregnancy rate
fetal heart activity
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start15 Oct 2020 (estimated)
- Primary completion20 Nov 2020 (estimated)
- Study completion25 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMHStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al Baraka Fertility Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Kamal Rageh, Al Baraka Fertility Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04512807
- Sponsor's protocol ID
- Dr. Atyaf Aldawodi
- Status last verified
- Oct 2020
- First submitted
- 11 Aug 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Anti-mullerian Hormone and Pregnancy Outcome in IVF
- ClinicalTrials.gov ID
- NCT04512807
- Acronym / sponsor ID
- Dr. Atyaf Aldawodi
- Conditions
- AMH
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Al Baraka Fertility HospitalUniversity, hospital or other
- Study start
- 15 Oct 2020 (estimated)
- Primary completion
- 20 Nov 2020 (estimated)
- Study completion
- 25 Nov 2020 (estimated)
- First posted
- 14 Aug 2020 (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.
Anti-Mu¨llerian hormone (AMH) is an established marker of ovarian reserve (La Marca et al., 2010; Nelson et al., 2009) and predicts both high and low responses in ovarian stimulation cycles (Eldar-Geva et al., 2005; Nardo et al., 2009; Nelson et al., 2007). Presently, AMH helps clinicians counsel patients prior to IVF treatment (La Marca et al., 2011), despite the fact that it fails to predict who will become pregnant (Lamazou et al., 2011; Riggs et al., 2011). It has been demonstrated that poor responders can achieve both pregnancy and live birth (Weghofer et al., 2011). There are few studies regarding extremely low AMH concentrations and live births (Fraisse et al., 2008; Tocci et al., 2009; Weghofer et al., 2011) and they present either a small number of patients or limited data describing the groups of investigated patients. Another factor affecting pregnancy rates is endometriosis, a chronic gynaecological disease characterized by the presence of functional endometrial tissue outside the uterine cavity (Koninckx et al., 1991). Many studies have reported that pregnancy rates are lower in women with endometriosis than in controls (Gupta et al., 2008; Koninckx et al., 1991 Pellicer et al., 2000). Lower AMH serum concentrations are associated with endometriosis severity (Shebl et al., 2006). The primary objective of the present study was to assess the clinical pregnancy rates in women with extremely low AMH concentrations with respect to age.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 22 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with low or very low AMH
Key inclusion criteria (1 listed)
- Women ≥22 years age AMH is 0.5 and less Body mass index- 18.5-30 kg/m 2 The normal uterine cavity on ultrasound scan At least one good quality embryo present for transfer Women willing to comply with the clinical study protocol
Key exclusion criteria (4 listed)
- Women ≥ 45 years age
- AMH >0.5
- Uterine abnormalities that can compromise the IRs (e.g., endometrial polyp, fibroids, hydrosalpinx, and adenomyosis)
- Endocrine dysfunction or organ dysfunction such as liver or kidney failure.
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 |
|---|---|---|
| AMHAMH \& PREGNANCY | Diagnostic test | – |
Primary outcome
pregnancy test
Time frame: 2 weeks
B-HCG
clinical pregnancy rate
Time frame: 4 weeks
fetal heart activity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of AMH, run by Al Baraka Fertility Hospital.
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 4 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 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
pregnancy test (time frame: 2 weeks). The study lists 2 primary outcomes in all. 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 22 Oct 2020.