Infertility, FemaleNCT03291860
Antimullerian Hormone as an Indicator for Ovarian Response
An observational study of Infertility, Female, run by Ain Shams Maternity Hospital.
Trial summary
Anti Mullerian hormone (AMH) is gaining place as ovarian marker, chiefly in infertility assistance. Investigators explored its correlation with oocytes retrieval after long GnRH agonist protocol for stimulation, in younger and older infertile population. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Ovum retrievum
- Type of treatment
- Surgery or procedure
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2017to 10 Oct 2018
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Sixty six women undergoing ICSI were enrolled in and a written informed consent was obtained from each participant
Who may be able to join
- Age:20-40 years old
- BMI:20-40kg/m
- Normal baseline hormonal profile (on the 2nd day of the cycle)
- FSH: 2.5-10.2mlU/ml
- LH:1.9-12.5mlU/ml
- Estradiol (E2): <50pg/ml
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- No Endometriosis by laparoscopy
- No prior ovarian surgery; overectomy, ovariectomy or oophrectomy
- Female subjects who have at least 1 wash-out cycle (defined as greater than or equal to 30 days since the last dose of clomiphene citrate or gonadotrophin treatment) since the last ART cycle and/or clomiphene citrate or gonadotrophin treatment prior to starting gonadotrophin releasing hormone (GnRH) agonist therapy
Who cannot join
- 1. Age: <20 or >40 years old 2. BMI: <20 or >40kg/m 3. Female subjects with any contraindication for pregnancy. 4. Female subjects with history of tumors of the hypothalamus \& pituitary gland.
- 5. Female subjects with history of ovarian, uterine or mammary cancer. 6. Female subjects with history of hypersensitivity to the active substance of the medications used for ovarian stimulation.
- 7. Abnormal baseline hormonal profile 8. Endometriosis by laparoscopy 9. Previous ovarian surgery; overectomy, ovariectomy or oophrectomy 10. Female subjects with abnormal gynecological bleeding of unknown etiology
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Antimullerian Hormone as an Indicator fo Ovarian Response in Women Receiving Long GnRH Agonist Protocol in Intracytoplasmic Sperm Injection Cycles
Anti Mullerian hormone (AMH) is gaining place as ovarian marker, chiefly in infertility assistance.
Investigators explored its correlation with oocytes retrieval after long GnRH agonist protocol for stimulation, in younger and older infertile population. Methods: This prospective analysis compiled data of 66 females, receiving ICSI treatment from April 2016 to October 2017. Serum FSH, LH, Estadiol, AMH and antral follicle count were assessed. Outcomes were measured as good (5 to 19 oocytes) and bad responders.
- Conditions
- Infertility, Female
- Being tested
- Ovum retrievum
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ovum retrievumProcedure or surgery
assessment of oocytes collected by ovum retrievum to evaluate the discriminatory power of the antimullerian hormone in ICSI cycles
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between AMH levels between good and poor responders in young patients receiving long GnRH agonist protocol for ICSI.
Measurement of AMH level in patients undergoing controlled ovarian stimulation prior to ICSI using long GnRH agonist protocol. Level will be compared between good and poor responders.
Measured: 1 month (1 cycle)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start10 Nov 2017 (estimated)
- Primary completion10 Sep 2018 (estimated)
- Study completion10 Oct 2018 (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
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohammed Selim, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03291860
- Sponsor's protocol ID
- Antimullerian hormone
- Status last verified
- Sep 2017
- First submitted
- 18 Sep 2017
- Last updated
- 25 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antimullerian Hormone as an Indicator fo Ovarian Response in Women Receiving Long GnRH Agonist Protocol in Intracytoplasmic Sperm Injection Cycles
- ClinicalTrials.gov ID
- NCT03291860
- Acronym / sponsor ID
- Antimullerian hormone
- Conditions
- Infertility, Female
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- 10 Nov 2017 (estimated)
- Primary completion
- 10 Sep 2018 (estimated)
- Study completion
- 10 Oct 2018 (estimated)
- First posted
- 25 Sep 2017 (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 Mullerian hormone (AMH) is gaining place as ovarian marker, chiefly in infertility assistance.
Investigators explored its correlation with oocytes retrieval after long GnRH agonist protocol for stimulation, in younger and older infertile population. Methods: This prospective analysis compiled data of 66 females, receiving ICSI treatment from April 2016 to October 2017. Serum FSH, LH, Estadiol, AMH and antral follicle count were assessed. Outcomes were measured as good (5 to 19 oocytes) and bad responders.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Sixty six women undergoing ICSI were enrolled in and a written informed consent was obtained from each participant
Key inclusion criteria (9 listed)
- Age:20-40 years old
- BMI:20-40kg/m
- Normal baseline hormonal profile (on the 2nd day of the cycle)
- No Endometriosis by laparoscopy
- No prior ovarian surgery; overectomy, ovariectomy or oophrectomy
Key exclusion criteria (3 listed)
- 1. Age: <20 or >40 years old 2. BMI: <20 or >40kg/m 3. Female subjects with any contraindication for pregnancy. 4. Female subjects with history of tumors of the hypothalamus \& pituitary gland.
- 5. Female subjects with history of ovarian, uterine or mammary cancer. 6. Female subjects with history of hypersensitivity to the active substance of the medications used for ovarian stimulation.
- 7. Abnormal baseline hormonal profile 8. Endometriosis by laparoscopy 9. Previous ovarian surgery; overectomy, ovariectomy or oophrectomy 10. Female subjects with abnormal gynecological bleeding of unknown etiology
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 |
|---|---|---|
| Ovum retrievumassessment of oocytes collected by ovum retrievum to evaluate the discriminatory power of the antimullerian hormone in ICSI cycles | Procedure or surgery | – |
Primary outcome
Difference between AMH levels between good and poor responders in young patients receiving long GnRH agonist protocol for ICSI.
Time frame: 1 month (1 cycle)
Measurement of AMH level in patients undergoing controlled ovarian stimulation prior to ICSI using long GnRH agonist protocol. Level will be compared between good and poor responders.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Female, run by Ain Shams Maternity 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 9 inclusion and 3 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 25 Sep 2017. 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?
Contact Ahmed M Selim, MBBCh (00201123122003, dr.ahmedselim_89@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between AMH levels between good and poor responders in young patients receiving long GnRH agonist protocol for ICSI. (time frame: 1 month (1 cycle)). 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 25 Sep 2017.