Double Stimulation in Women With Low Prognosis in ART

Tu Du Hospital

Status: Enrolling

Conditions: Assisted Reproductive Techniques

Treatments: Procedure: conventional ovarian stimulation; Procedure: double stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04531644

CS/TD/20/05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Study

Experimental group

Description:

the patients in this group will be treated with double stimulation

Treatment:

Procedure: double stimulation

Control

Active Comparator group

Description:

the patients in this group will be treated with conventional ovarian stimulation

Treatment:

Procedure: conventional ovarian stimulation