NCT03291860

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2017

Shorter than P25 for all trials

Status
unknown

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

September 18, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 25, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

November 10, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2018

Completed
Last Updated

September 25, 2017

Status Verified

September 1, 2017

Enrollment Period

10 months

First QC Date

September 18, 2017

Last Update Submit

September 22, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 month (1 cycle)

Interventions

assessment of oocytes collected by ovum retrievum to evaluate the discriminatory power of the antimullerian hormone in ICSI cycles

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Sixty six women undergoing ICSI were enrolled in and a written informed consent was obtained from each participant

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • \. 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.
  • \. 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.
  • \. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Central Study Contacts

Ahmed M Selim, MBBCh

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

September 18, 2017

First Posted

September 25, 2017

Study Start

November 10, 2017

Primary Completion

September 10, 2018

Study Completion

October 10, 2018

Last Updated

September 25, 2017

Record last verified: 2017-09