Double Stimulation in Women With Low Prognosis in ART

Not Applicable

Recruiting

• Conditions: Assisted Reproductive Techniques
• Interventions: Procedure: double stimulation; Procedure: conventional ovarian stimulation

• Registration Number: NCT04531644
• Lead Sponsor: Tu Du Hospital

Brief Summary

The main objective of this study is to compare the cumulative ongoing pregnancy rates of two different IVF protocols in women candidate for ART characterized by low prognosis.

Detailed Description

The patients will be allocated into two groups: control and study group _ In study group, patients will be treated by DuoStim protocol: The first phase of ovarian stimulation is started on the second day or third day of period. GnRH agonist will be used to trigger when at least two follicles ≥ 17 mm. Approximately 36 hours later, oocytes will be retrieved vaginally under ultrasound monitoring and ICSI will be performed. Five days later after oocyte retrieval, the second stimulation will be started. All embryos will be cryopreserved.

_ In control group, patients will be treated with antagonist protocol: The cycle of ovarian stimulation is started on the second day or third day of period. hCG will be used to trigger when at least two follicles ≥ 17 mm. Approximately 36 hours later, oocytes will be retrieved vaginally under ultrasound monitoring and ICSI will be performed. If serum progesterone on the day of trigger ≥ 1.5 ng/ml, all embryos will be cryostored; otherwise, fresh embryos will be transferred.

Study Timeline

• Study Start: 2020-05-14
• Study First Submitted: 2020-08-18
• Study First Submitted QC: 2020-08-26
• Study First Posted: 2020-08-28
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-04
• Last Update Posted: 2023-12-06
• Primary Completion: 2024-02-28
• Study Completion: 2024-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Age ≤ 40.
• AMH ≥ 0.3 ng/ml and ≤ 1.2 ng/ml.
• OR 3 ≤ AFC ≤7.
• Normal shape of uterus (based on ultrasound).
• Body mass index within 28 - 37 kg/m2

Exclusion Criteria

• Asherman's syndrome.
• Endometriosis.
• Leiomyomas distorting the endometrium
• Sperm extracted from surgical procedures (i.e. PESA, TESE).
• Patients refuse to continue participating in the study.
• Patients injected with wrong dose of gonadotropins during the treatment.
• Serious complications or accidents arise forcing the patients to discontinue the treatments.
• Ovarian surgery
• Previous chemotherapy or pelvic irradiation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study	double stimulation	the patients in this group will be treated with double stimulation
Control	conventional ovarian stimulation	the patients in this group will be treated with conventional ovarian stimulation

Primary Outcome Measures

Name	Time	Method
Cumulative Ongoing pregnancy rate	week 11 - 14 of pregnancy	calculated by the number of ongoing pregnancy patients divided by the total number of patients in appropriate group

Secondary Outcome Measures

Name	Time	Method
Fertilization rate	1 to 3 days after oocyte pick-up	number of fertilized oocyted divided by number of mature oocytes
Pregnancy rate	2 weeks after embryo transfer	beta-hCG test is positive
Number of mature oocytes	4 hours after oocyte pick-up	Number of mature oocytes identified by the embryologists
Ongoing pregnancy rate	week 11 - 14 of pregnancy	defined as the pregnancy completed 11 - 14 weeks of gestation and having vital fetus
Number of oocytes retrieved	4 hours after occyte pick-up	Number of oocytes retrieved identified by the embryologists
Number of competent embryos	3 days to 5 days after oocyte pick-up	Number of embryos that can be transferred

Trial Locations

Locations (1)

Department of Infertility of Tu Du hospital; 🇻🇳 Ho Chi Minh City, Vietnam