Clinical trial NCT01926210: Comparison of Ovarian Mild Stimulation and Controlled Ovarian Stimulation in Poor Ovarian Responders
Official title: The Comparison of Mild Stimulation and Controlled Ovarian Stimulation in Poor Ovarian Responders: a Prospective Randomized Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Infertility
Keywords: Poor ovarian response
in vitro fertilization
mild ovarian stimulation
controlled ovarian stimulation
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2013-08-20
Enrollment: 500
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: clinical pregnancy rate
timeFrame: 7 weeks
Secondary outcomes:
measure: live birth rate
timeFrame: 10 months
measure: Number of oocytes retrieved
timeFrame: 3 weeks
measure: Number of transferrable embryo
timeFrame: 3 weeks
measure: normal fertilization rate
timeFrame: 3 weeks
measure: implantation rate
timeFrame: 7 weeks
measure: ongoing pregnancy rate
timeFrame: 3 months
measure: Total dose of recombinant FSH consumption
timeFrame: 3 weeks
measure: length of stimulation
timeFrame: 3 weeks
measure: serum estradiol level
timeFrame: 3 weeks
measure: serum LH level
timeFrame: 3 weeks
measure: serum progesterone level
timeFrame: 3 weeks
measure: serum FSH level
timeFrame: 3 weeks
measure: FSH level in follicular fluid
timeFrame: 3 weeks
measure: LH level in follicular fluid
timeFrame: 3 weeks
measure: Estradiol level in the follicular fluid
timeFrame: 3 weeks
measure: progesterone level in follicular fluid
timeFrame: 3 weeks
measure: testerone level in the follicular fluid
timeFrame: 3 weeks
measure: anti-müllerian hormone (AMH)level in follicular fluid
timeFrame: 3 weeks
measure: Ovarian Hyperstimulation Syndrome (OHSS) rate
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: sixth affiliated hospital of Sun Yet-san University
state: Guangdong
Study officials:
affiliation: sixth affiliated hospital of Sun Yet-san University
name: Rui Huang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: