Clinical trial NCT02132559: Effect of Dehydroepiandrosterone Administration in Patients With Poor Ovarian Response According to the Bologna Criteria
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Lead sponsor: Chinese Medical Association
Sponsor class: NETWORK
First posted: 2014-05-07
Enrollment: 386
Sex: FEMALE
Minimum age (years): 23
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.


Eligibility criteria: Inclusion Criteria:

Patients with poor ovarian response according to the Bologna criteria

Exclusion Criteria:

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

Primary outcomes:
measure: ongoing pregnancy rates
timeFrame: 12 weeks after gestation.
Secondary outcomes:
measure: Clinical pregnancy rate
timeFrame: 28 days after the embryo transfer
measure: the number of retrieved oocytes
timeFrame: 36-37 hrs after hCG administration
measure: Fertilization rate
timeFrame: on day 1 after oocyte retrieval
measure: Cleavage rate
timeFrame: on day 2 or 3 after oocyte retrieval
measure: Implantation rate
timeFrame: 28 days after the embryo transfer
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Reproductive Medicine Center, Tongji Hospital, Tongji Medicine College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Reproductive Medicine Center, Tongji Hospital, Tongji Medicine College, Huazhong University of Science and Technology
name: Guijin Zhu
role: STUDY_DIRECTOR
References: