Recruitment

Recruitment Status
Completed

Inclusion Criterias

Indicated for IVF treatment according to our standard department protocol
AFC not more than 15
Age < 40
...
Indicated for IVF treatment according to our standard department protocol
AFC not more than 15
Age < 40
Regular menstrual cycles (21-35 days with </= 4 days inter-cycle variation)

Exclusion Criterias

Previous chemotherapy or pelvic irradiation
On hormonal supplementation for any indication at the time of recruitment (e.g. estrogen, testosterone or DHEA)
Polycystic ovarian syndrome or polycystic ovaries
Previous chemotherapy or pelvic irradiation
On hormonal supplementation for any indication at the time of recruitment (e.g. estrogen, testosterone or DHEA)
Polycystic ovarian syndrome or polycystic ovaries

Summary

Conditions
Female Infertility Due to Diminished Ovarian Reserve
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Single Group Assignment
  • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 40 years
Gender
Only females

Description

Consecutive patients attending subfertility clinic at the Department of Obstetrics and Gynaecology, Queen Mary Hospital who are scheduled for in-vitro fertilization (IVF) treatment will be recruited and written consent will be obtained. Baseline assessment will be performed at early follicular phase...

Consecutive patients attending subfertility clinic at the Department of Obstetrics and Gynaecology, Queen Mary Hospital who are scheduled for in-vitro fertilization (IVF) treatment will be recruited and written consent will be obtained. Baseline assessment will be performed at early follicular phase (Day 2 or 3) with hormonal tests and ultrasound. Subjects will be divided into two groups, the normal ovarian reserve group and the poor ovarian reserve group according to AFC. Poor ovarian reserve is defined as an AFC of less than 5, while normal ovarian reserve is defined as an AFC of 5 to 15 based on a previous study showing AFC being a good predictor of ovarian response (Tomas 1997). Subjects with normal ovarian reserve will be further subdivided into <35 and >/=35 years old while subjects with poor ovarian reserve will be further subdivided into first or subsequent cycles of IVF for subgroup analysis. Subjects in both the normal and poor ovarian reserve group will be randomized according to a computer-generated randomization list in sealed envelopes to receive either DHEA at 25mg three times a day or placebo throughout the study period. Any changes in hormonal profile and ovarian reserve will be assessed by the above-mentioned blood tests and pelvic ultrasound scans which will be repeated at early follicle phase (Day 2 or 3) in the two subsequent cycles. After two months of DHEA/placebo treatment, the subjects will then be given a standard low dose ovarian stimulation with 75 IU intramuscular human menopausal gonadotrophin (HMG, Menogon®, Ferring Pharmaceuticals) daily for 7 days. Blood tests and pelvic ultrasound scan will be repeated after 7 days of stimulation (ie. on day 10 or 11). Hormonal profile and ovarian reserve will be repeated in follicular phase (D2 or 3) in the subsequent cycle, where all patients will then be offered a cycle of IVF treatment using antagonist protocol based on our standard departmental regimen. Cycle characteristic and pregnancy outcomes will be compared. Analysis of ovarian reserve markers, ovarian response and IVF outcomes would be performed.

Inclusion Criterias

Indicated for IVF treatment according to our standard department protocol
AFC not more than 15
Age < 40
...
Indicated for IVF treatment according to our standard department protocol
AFC not more than 15
Age < 40
Regular menstrual cycles (21-35 days with </= 4 days inter-cycle variation)

Exclusion Criterias

Previous chemotherapy or pelvic irradiation
On hormonal supplementation for any indication at the time of recruitment (e.g. estrogen, testosterone or DHEA)
Polycystic ovarian syndrome or polycystic ovaries
Previous chemotherapy or pelvic irradiation
On hormonal supplementation for any indication at the time of recruitment (e.g. estrogen, testosterone or DHEA)
Polycystic ovarian syndrome or polycystic ovaries

Locations

Hong Kong
Hong Kong

Tracking Information

NCT #
NCT01915186
Collaborators
Not Provided
Investigators
Not Provided