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Novel Therapy for Poor Responders Management

Sponsor
Al Baraka Fertility Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT04310293
Collaborator
(none)
100
Enrollment
1
Location
1
Arm
4.7
Anticipated Duration (Months)
21.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Unfortunately for some infertile women, gonadotrophin administration results in a desultory ovarian response. While this is commonly due to diminished ovarian reserve, as indicated by advanced age and/or elevated basal day 3 FSH concentrations, a subset of these patients are <41 years old and have normal FSH concentrations.

To overcome this problem several strategies have been reported, with limited success.

With approval of the Board, 100 women with a history of previous poor response to vigorous gonadotrophin stimulation. All with AFC ≤3, AMH;≤0.5 and they give only ≤3 oocytes in their previous cycles will be included in this study using this new protocol: clomiphene citrate 150 for 7 days starting on DAY2, associated with HMG 300 IU & Groth hormone 8 units in alternating days (i.e.; HMG on D2,4,6,8 while GH on D3,5,7,9) then folliculomonitoring will be started on D9, then Antagonist may be added till triggering then will see the response compared to their own ovarian response before

Condition or Disease Intervention/Treatment Phase
  • Other: Femara,Grotwth hormone,HMG
 N/A

Detailed Description

Unfortunately for some infertile women, gonadotrophin administration results in a desultory ovarian response. While this is commonly due to diminished ovarian reserve, as indicated by advanced age and/or elevated basal day 3 FSH concentrations, a subset of these patients are <41 years old and have normal FSH concentrations.

To overcome this problem several strategies have been reported, with limited success.

With approval of our Board, 100 women with a history of previous poor response to vigorous gonadotrophin stimulation. All with AFC ≤3, AMH;≤0.5 and they give only ≤3 oocytes in their previous cycles will be included in this study using this new protocol: clomiphene citrate 150 for 7 days starting on DAY2, associated with HMG 300 IU & Groth hormone 8 units in alternating days (i.e.; HMG on D2,4,6,8 while GH on D3,5,7,9) then folliculomonitoring will be started on D9, then Antagonist may be added till triggering then will see the response compared to their own ovarian response before in their previous trials

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Novel Therapy for Poor Responders Management
Actual Study Start Date :
Mar 10, 2020
Anticipated Primary Completion Date :
Aug 1, 2020
Anticipated Study Completion Date :
Aug 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Other: POOR RESPONDERS

poor responders low AMH LOW AFC

Other: Femara,Grotwth hormone,HMG
NOVEL THERAPY

Outcome Measures

Primary Outcome Measures

  1. NUMBER OF OOCYTES [2 weeks]

    NUMBER

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • All with AFC ≤3,

  • AMH;≤0.5

  • and they give only ≤3 oocytes in their previous cycles

Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Al-BARAKA FERTILITY HOSPITAL Manama Bahrain 15006

Sponsors and Collaborators

  • Al Baraka Fertility Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Kamal Rageh, medical director, Al Baraka Fertility Hospital
ClinicalTrials.gov Identifier:
NCT04310293
Other Study ID Numbers:
  • Kamal-Rageh
First Posted:
Mar 17, 2020
Last Update Posted:
Jul 8, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr. Kamal Rageh, medical director, Al Baraka Fertility Hospital
IVF
POOR RESPONDERS
GROWTH HORMONE
Additional relevant MeSH terms:
Hormones

Study Results

No Results Posted as of Jul 8, 2020