Does DHEA IVF Outcomes in Poor Responders?

NCT04066478 | Suspended Phase 2 DMC

• 1 other identifier: 2017DHEA
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Infertility, Female; Poor Response to Ovulation Induction

Outcome Measures

Primary Outcomes (1)

• Clinical pregnancy rates

  ultrasound confirmation of a foetus with a heartbeat

  at 6-8 weeks gestation

Study Arms (2)

Teatment

EXPERIMENTAL

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

Drug: Dehydroepiandrosterone

Comaprator

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Dehydroepiandrosterone DRUG

75mg Dehydroepiandrosterone daily

Teatment

Placebo DRUG

Placebo

Comaprator

Eligibility Criteria

• Age: 40 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Homerton University Hospital NHS Foundation Trust: lead

Study Sites (1)

Homerton Fertility Centre

London, E9 6SR, United Kingdom

Location

MeSH Terms

Conditions

Infertility, Female

Interventions

Dehydroepiandrosterone

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 17-Ketosteroids; Ketosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised, double-blind, placebo controlled study

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: August 26, 2019
• Study Start: October 8, 2017
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: June 23, 2022

Record last verified: 2022-06

Locations

GB (1)