Cumulative Live Birth Rates in Dual Ovarian Stimulation Versus Two Antagonist Stimulations in Poor Ovarian Responders

ConditionInfertility
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-44
SponsorShanghai First Maternity and Infant Hospital

About this trial

To compare the difference in cumulative live birth rates between dual ovarian stimulation and two antagonist stimulations in poor ovarian responders.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women with POR were defined with adjusted Bologna criteria, at least two of the three following criteria: advanced maternal age (40 years); 3 oocytes in previous IVF; and antral follicle count (AFC) 5 and/or anti-Mu¨llerian hormone (AMH) 1.1 ng/ml (this criterion was mandatory)

Aged from 20 to 44 years

Body mass index (BMI) from 19 to 32 kg/m2

No more than two previous IVF cycles were recruited

Disqualifiers

Amenorrhoea

Follicle stimulating hormone (FSH) 20 IU/L or AFC 1

Women with a partner with an extremely severe sperm anomaly or sperm donor use

Trial design

Design model

Parallel

Treatments tested in this trial

  • duostim vs. two antagonist ovarian stimulations

    Procedure/Surgery

    Human menopausal gonadotropin (HMG) 300 IU/day with flexible antagonist protocol is used for ovarian stimulation, except in luteal phase stimulation of the duostim group. In the duostim group, all of the embryos are frozen. Fresh transfers are performed in the control group, frozen embryo transfers are performed in both control and duostim groups.

Treatment groups

260 Participants
are divided into 2 treatment groups
Group A: Dual Stimulation ProtocolExperimental treatment 1 intervention
Group B: Antagonist Stimulation ProtocolActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cumulative live birth rate

Live birth is defined as the delivery of any alive infant after 22 weeks of gestation after our interventions, and cumulative live birth rate is calculated by the total number of women randomized to the specific group.

Time frame
36 months

Secondary outcomes

1

Time to live birth (TTLB)

The TTLB was measured as the time from ovarian stimulation to a live birth.

Time frame
36 months
2

Total amount of Gn used during ovarian stimulation

Total amount of Gn used during ovarian stimulation

Time frame
24 months
3

Number of retrieved oocytes

Number of retrieved oocytes after ovarian stimulation.

Time frame
24 months
4

Clinical pregnancy rate

Twenty days after conception, transvaginal ultrasonography will be performed. Clinical pregnancy will be diagnosed with detection of an intrauterine gestational sac.

Time frame
36 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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