NCT02673632

Brief Summary

The investigator suggests that PCOS women with high AMH levels are resistant to ovarian stimulation and may need adjustment of the dose of gonadotrophin.

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
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 2, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 4, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

February 4, 2016

Status Verified

February 1, 2016

Enrollment Period

3 months

First QC Date

February 2, 2016

Last Update Submit

February 3, 2016

Conditions

Infertility

Keywords

Anti-Müllerian hormoneOvarian stimulationPolycystic ovary syndromeIntracytoplasmic sperm injection

Outcome Measures

Primary Outcomes (1)

  • Good response to hMG therapy defined as occurrence of > 3 mature follicles after treatment.

    Good response to hMG therapy defined as occurrence of \> 3 mature follicles after treatment.

    30 days

Interventions

Merional ®DRUG

Using the long protocol of controlled ovarian hyperstimulation (COH). Down regulation by (Decapeptyl ®, Ferring) 0.1mg subcutaneously once daily starting from day 18 of the preceding cycle, human menopausal gonadotrophin (hMG) (Merional ®, IBSA) 75 IU starting from cycle day two after confirmation of down regulation (thin endometrium, number of follicular activity, E2 \< 50 pg/mL). hMG dose is optimized according to age, BMI, antral follicles count (AFC), the local protocol, FSH level and previous response. Usually PCO patients start by 150 IU.

Also known as: Decapeptyl ®

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The study population comprises women with PCOS, fulfilling the inclusion criteria, attending to Ain Shams University Maternity Hospital, assisted reproductive technology (ART) Unit, during the study period, who are planning for Intracytoplasmic sperm injection (ICSI).

You may qualify if:

  • Women of age 18 - 35 years
  • BMI 20 - 30 kg/m2
  • Anovulatory infertility
  • Diagnosis of PCOS based on Rotterdam consensus criteria (two of three criteria: Oligo/anovulation, hyperandrogenaemia and sonographic appearance of polycystic ovaries)

You may not qualify if:

  • Women Above 35 years or under 18 years
  • Women with BMI above 30 kg/m2 or under 20 kg/m2
  • Normally ovulating women
  • Patients with marked hyperandrogenaemia were screened for congenital adrenal hyperplasia (by measuring serum concentration of 17alpha hydroxyl-progesterone) or Patients with Cushing syndrome (by measuring urinary free cortisol)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Amer SA, Mahran A, Abdelmaged A, El-Adawy AR, Eissa MK, Shaw RW. The influence of circulating anti-Mullerian hormone on ovarian responsiveness to ovulation induction with gonadotrophins in women with polycystic ovarian syndrome: a pilot study. Reprod Biol Endocrinol. 2013 Dec 17;11:115. doi: 10.1186/1477-7827-11-115.

    PMID: 24341292BACKGROUND

MeSH Terms

Conditions

InfertilityPolycystic Ovary Syndrome

Interventions

hMG-IBSATriptorelin Pamoate

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesOvarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Central Study Contacts

Karim L Emam, MBBCH

CONTACT

+201001001696kl_emam@hotmail.com

Ahmed M Bahaa eldin, A.Professor

CONTACT

+20 1111700556abahaa0503@med.asu.edu.eg

Study Design

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

Study Record Dates

First Submitted

February 2, 2016

First Posted

February 4, 2016

Study Start

February 1, 2016

Primary Completion

May 1, 2016

Study Completion

August 1, 2016

Last Updated

February 4, 2016

Record last verified: 2016-02