Does DHEA IVF Outcomes in Poor Responders?

Homerton University Hospital NHS Foundation Trust

Status and phase: Suspended; Phase 3; Phase 2

Conditions: Poor Response to Ovulation Induction; Infertility, Female

Treatments: Drug: Dehydroepiandrosterone; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04066478

2017DHEA

Details and patient eligibility

About

This study is a RCT to examine whether DHEA is capable of improving results for poor responders to ovarian stimulation during IVF treatment

Full description

Poor responders to ovarian stimulation for IVF may be either predicted or evidenced from previous treatment. The ESHRE criteria for poor responders will be used to select candidates for this trial. A power calculation determined that 200 subjects should be recruited to each arm to receive either DHEA or placebo.

Enrollment: 400 estimated patients

Sex: Female

Ages: 40 to 42 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 40 years
• Markers for poor ovarian reserve (AMH <7 pmol/L(<1.1 ng/ml) and/or AFC< 7)
• Previous poor response to ovarian stimulation ( ≤3 oocytes with a conventional stimulation protocol)

Exclusion criteria

• Women > 42 years
• Women with premature ovarian failure / premature menopause (FSH>40 U/L). Women already taking DHEA.
• Patients with a known allergy to the trial drug or any of the active ingredients in the placebo.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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400 participants in 2 patient groups, including a placebo group

Teatment

Experimental group

Description:

75mg Dehydroepiandrosterone once daily for minimum ten weeks prior to starting ovarian stimulation

Treatment:

Drug: Dehydroepiandrosterone

Comaprator

Placebo Comparator group

Description:

75mg placebo once daily for minimum ten weeks prior to starting ovarian stimulation

Treatment:

Drug: Placebo