Comparison of Ovarian Mild Stimulation and Controlled Ovarian Stimulation in Poor Ovarian Responders (POR)

August 20, 2013 updated by: Huang Rui

The Comparison of Mild Stimulation and Controlled Ovarian Stimulation in Poor Ovarian Responders: a Prospective Randomized Study.

This is a prospective, randomized clinical trial to compare the efficiency and safety of mild stimulation and controlled ovarian stimulation protocol on the treatment of POR. The randomization is achieved on the basis of a computer-generated randomization list in a 1:1 ratio.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

500 poor ovarian responders will be equally randomized to two different ovarian stimulation protocol arms,i.e, mild ovarian stimulation(experimental arm) or controlled ovarian stimulation(control arm). In experimental arm, patients will received letrozole 5mg per day from cycle day 3 to 7 and recombinant follicle-stimulating hormone (FSH) 150 international unit (IU) on day 4 and 6. The dose of recombinant FSH is adjusted according to the ovarian response and the gonadotropin-releasing hormone(GnRH)antagonist(Cetrotide) 0.25mg per day is administrated when the estradiol level reaches 200 pg/ml and the serum luteinizing hormone （LH）level rises above 2 times of basal LH level. In control arm,patients will be stimulated with short-acting GnRH agonist long protocol. After complete downregulation is achieved through GnRH-agonist, recombinant FSH 300 IU/d is given for 5 days, then the dose of recombinant FSH is adjusted according to ovarian response.

The clinical and ongoing pregnancy rate and other secondary outcome parameters are compared between these two groups.

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510010
        • sixth affiliated hospital of Sun Yet-san University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • a. Poor ovarian responders b. Normal BMI (18-25 Kg/m2) c. Regular menstruation (with cycle 23-35 days)

Exclusion Criteria:

  • a. History of repeated IVF failure (previous IVF cycle >2) b. Serious adenomyosis c. Polycystic ovary syndrome(PCOS) patients d. History of allergic to ovulation induction medicines e. Abnormal uterine cavity, i.e, intrauterine adhesion f. Attending other clinical trials in the same period. g. History of systemic disease contradictory to COH or pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mild ovarian stimulation
Patients are stimulated with mild ovarian stimulation protocol,i.ed, from cycle day 3 to 7, letrozole 5mg per day are administrated and recombinant FSH 150 IU are given on day 4 and 6 . On cycle day 8, serum FSH LH, and estradiol levels are measured, and after then, the dose of recombinant FSH is adjusted according to the ovarian response and the maxim recombinant FSH dose is 150 IU/d. The GnRH-antagonist (Cetrotide) 0.25mg per day is administrated when the estradiol level reaches 200 pg/ml and the serum LH level rises above 2 times of basal LH level.
Other: mild stimulation protocol
letrozole is used from cycle day 3 to 7 and low dose recombinant FSH(no more than 150 IU/d) is used on cycle day 4,6 and 8 onwards. GnRH antagonist is only applied in case of premature LH rise might happen.
Other Names:
  • recombinant FSH
  • letrozole
  • GnRH antagonist
Active Comparator: controlled ovarian stimulation
Patients are stimulated using controlled ovarian stimulation protocol,i.e., from cycle day 18-22 (day 7 after ovulation) of previous cycle, all participants are given short-acting GnRH agonist (Triptorelin 0.05mg/d) for 14 days, then after checking serum FSH, LH and estradiol to make sure that complete downregulation is achieved, exogenous gonadotropin (recombinant FSH) 300 IU/d is given for 5 days, then the dose of recombinant FSH is adjusted according to ovarian response.
Other: controlled ovarian stimulation
After fully downregulation by using short-acting GnRH agonist, 300 IU/d recombinant FSH is administrated for 5 days, then the dose is adjusted according to ovarian response.
Other Names:
  • recombinant FSH
  • GnRH agonist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
clinical pregnancy rate
Time Frame: 7 weeks
7 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
live birth rate
Time Frame: 10 months
10 months
Number of oocytes retrieved
Time Frame: 3 weeks
3 weeks
Number of transferrable embryo
Time Frame: 3 weeks
3 weeks
normal fertilization rate
Time Frame: 3 weeks
3 weeks
implantation rate
Time Frame: 7 weeks
7 weeks
ongoing pregnancy rate
Time Frame: 3 months
3 months
Total dose of recombinant FSH consumption
Time Frame: 3 weeks
3 weeks
length of stimulation
Time Frame: 3 weeks
3 weeks
serum estradiol level
Time Frame: 3 weeks
3 weeks
serum LH level
Time Frame: 3 weeks
3 weeks
serum progesterone level
Time Frame: 3 weeks
3 weeks
serum FSH level
Time Frame: 3 weeks
3 weeks
FSH level in follicular fluid
Time Frame: 3 weeks
3 weeks
LH level in follicular fluid
Time Frame: 3 weeks
3 weeks
Estradiol level in the follicular fluid
Time Frame: 3 weeks
3 weeks
progesterone level in follicular fluid
Time Frame: 3 weeks
3 weeks
testerone level in the follicular fluid
Time Frame: 3 weeks
3 weeks
anti-müllerian hormone (AMH)level in follicular fluid
Time Frame: 3 weeks
3 weeks
Ovarian Hyperstimulation Syndrome (OHSS) rate
Time Frame: 7 weeks
7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huang Rui

Investigators

  • Principal Investigator: Rui Huang, M.D., sixth affiliated hospital of Sun Yet-san University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Anticipated)

September 1, 2015

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

August 14, 2013

First Submitted That Met QC Criteria

August 16, 2013

First Posted (Estimate)

August 20, 2013

Study Record Updates

Last Update Posted (Estimate)

August 21, 2013

Last Update Submitted That Met QC Criteria

August 20, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-2013-01-05S

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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