CClinicalTrials.gg
Status unknownNCT04310293Updated Jul 8, 2020

Novel Therapy for Poor Responders Management

An interventional study of Femara,Grotwth hormone,HMG in Poor Ovarian Response, sponsored by Al Baraka Fertility Hospital. Status unknown at 1 site in Bahrain. Open to female participants aged 22 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-08.

Sponsored by Al Baraka Fertility Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
22 Years to 45 Years
Sex
Female
01

Study 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

Read the 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

02

Conditions studied

  • Poor Ovarian Response

Keywords

  • IVF
  • POOR RESPONDERS
  • GROWTH HORMONE
03

Who can participate

Ages eligible
22 Years to 45 Years
Sexes eligible
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

Exclusion Criteria:

-

04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Other
    POOR RESPONDERS

    poor responders low AMH LOW AFC

    Other: Femara,Grotwth hormone,HMG

Interventions

  • OtherFemara,Grotwth hormone,HMG

    NOVEL THERAPY

05

What researchers measure

Primary outcomes

  1. NUMBER OF OOCYTES

    NUMBER

    Time frame: 2 weeks

06

Study locations

1 of 1 sites recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04310293
Lead sponsor
Al Baraka Fertility Hospital
Responsible party
Dr. Kamal Rageh (medical director, Al Baraka Fertility Hospital) — Principal investigator
First posted
Mar 17, 2020
Start date
Mar 10, 2020
Primary completion
Aug 1, 2020 (estimated)
Completion
Aug 1, 2020 (estimated)
Last update
Jul 8, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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