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

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

Detailed Description
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Studies have shown the ability to obtain oocytes with equivalent quality from the follicular and the luteal phase, and a higher number of oocytes within one cycle when using dual ovarian stimulation (duostim). This could be particularly relevant for women with poor ovarian responders (POR). Whether the cumulative live birth rates differ after duostim and two antagonist stimulations in POR remains controversial.

Official Title
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A Randomized Clinical Trial Comparing Cumulative Live Birth Rates in Dual Ovarian Stimulation Versus Two Antagonist Stimulations in Poor Ovarian Responders

Conditions
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Infertility

Intervention / Treatment
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* Procedure: duostim vs. two antagonist ovarian stimulations


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dual Stimulation Protocol<br>Dual stimulations were performed during the follicular and luteal phases in the same cycle. | Procedure: duostim vs. two antagonist ovarian stimulations<br>* 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.<br>|
| Active Comparator: Antagonist Stimulation Protocol<br>Antagonist stimulations were performed during two consecutive follicular phases in two cycles. | Procedure: duostim vs. two antagonist ovarian stimulations<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to live birth (TTLB) | The TTLB was measured as the time from ovarian stimulation to a live birth. | 36 months | 
| Total amount of Gn used during ovarian stimulation | Total amount of Gn used during ovarian stimulation | 24 months | 
| Number of retrieved oocytes | Number of retrieved oocytes after ovarian stimulation. | 24 months | 
| Clinical pregnancy rate | Twenty days after conception, transvaginal ultrasonography will be performed. Clinical pregnancy will be diagnosed with detection of an intrauterine gestational sac. | 36 months |