Effect of Dehydroepiandrosterone Administration in Patients With Poor Ovarian Response According to the Bologna Criteria

NCT02132559 | Completed DMC

• 1 other identifier: NSFC30901601
• Study Type: observational
• Target: 386
• Locations: 1 country
• Sites: 1

Brief Summary

Women with low ovarian reserve typically respond less well to the drugs used to stimulate the ovary during IVF treatment and produce fewer eggs and, as a result, are less likely to fall pregnant either naturally or after fertility treatment. The ideal stimulation regimen for poor responders is currently unknown. Dehydroepiandrosterone (DHEA) has been reported to improve pregnancy chances for poor responders, and is now utilized by approximately one third of all IVF centers world-wide. However, the current clinical evidence for DHEA on improvement of ovarian response and IVF outcome is insufficient. The validity of the results of the former studies, especially the varied inclusion criteria used to specify poor responders, is a subject of debate. Recently a uniform definition on poor ovarian response, the Bologna criteria, has been proposed by the European Society for Human Reproduction and Embryology(ESHRE). However, no studies have been performed study to evaluate the potential effects of DHEA supplementation according to these standards. The purpose of this study is to assess the impact of DHEA supplementation on IVF outcome of poor ovarian responders that fulfill the Bologna criteria.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• ongoing pregnancy rates

  12 weeks after gestation.

Secondary Outcomes (5)

• Clinical pregnancy rate

  28 days after the embryo transfer

• the number of retrieved oocytes

  36-37 hrs after hCG administration

• Fertilization rate

  on day 1 after oocyte retrieval

• Cleavage rate

  on day 2 or 3 after oocyte retrieval

• Implantation rate

  28 days after the embryo transfer

Study Arms (1)

DHEA administration,no treatment

The patients of study group received DHEA 25 mg orally,three times a day before the IVF cycle. Except for IVF, the control group of patients did not receive any pre-treatment.

Drug: DHEA

Interventions

DHEA DRUG

Also known as: dehydroepiandrosterone

DHEA administration,no treatment

Eligibility Criteria

• Age: 23 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

All patients were stratified according to the Bologna criteria for poor ovarian response. Poor responders were classified with at least two of the three following criteria: (I) advanced maternal age (≥40 years) or any other risk factor for POR; (II) a previous POR(≤3 oocytes with a conventional ovarian stimulation protocol); and (III) an abnormal ovarian reserve test (ORT): antral follicle count (AFC) \< 5-7 or serum anti-Mullerian hormone (AMH) \<0.5-1.1 ng/mL, as described by the Bologna criteria

You may qualify if:

• Patients with poor ovarian response according to the Bologna criteria

You may not qualify if:

• women aged \> 45 years or baseline follicle stimulating hormone(FSH)levels \>40 IU/l.

Sponsors & Collaborators

• Chinese Medical Association: lead

Study Sites (1)

Reproductive Medicine Center, Tongji Hospital, Tongji Medicine College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Infertility

Interventions

Dehydroepiandrosterone

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

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 Officials

• Guijin Zhu

  Reproductive Medicine Center, Tongji Hospital, Tongji Medicine College, Huazhong University of Science and Technology

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2014
• First Posted: May 7, 2014
• Study Start: October 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: May 7, 2014

Record last verified: 2013-07

Locations

CN (1)