Status:
UNKNOWN
The Effectiveness and Safety of the Prolonged Down-regulation Protocol for Controlled Ovarian Hyperstimulation
Lead Sponsor:
Peking University People's Hospital
Collaborating Sponsors:
West China Hospital
Peking University First Hospital
Conditions:
Infertility, Female
Eligibility:
FEMALE
20-35 years
Phase:
PHASE4
Brief Summary
Since the first "tube baby", Louise Brown, was born in the United Kingdom in 1978, many infertile couples have been benefitted from in vitro fertilization and embryo transfer (IVF-ET) and intracytopla...
Detailed Description
Background: Since the first "tube baby", Louise Brown, was born in the United Kingdom in 1978, many infertile couples have been benefitted from in vitro fertilization and embryo transfer (IVF-ET) and...
Eligibility Criteria
Inclusion
- Women aged between 20 to 35 years old and with a history of infertility (fail to get pregnant after over one year's regular, unprotected sex), who receive IVF/ICSI for one of the following reasons:
- ① Tubal factor: e.g. peritubal adhesions, tubal obstruction, etc.. Patients with hydrosalpinx can be enrolled after salpingectomy or tubal ligation;
- ② Male factor: e.g. oligospermia, asthenozoospermia, teratozoospermia, etc.;
- ③ Unexplained infertility: patients with a history of infertility more than 1 year but with no specific cause for infertility (ovulation, tubal, endometrial and male factor), or still not get pregnant after the above-mentioned causes being removed.
- Women with a normal ovarian reserve according to: ①basal steroid hormone on day 2-4 of menstrual cycle: basal FSH≤10mIU/ml, estradiol (E2) \<50pg/ml;②1.5\<anti-Müllerian hormone (AMH)\<4.0；③8≤antral follicle count (AFC) ≤15;
- First IVF/ICSI cycle;
- BMI≥18 and ≤25kg/m2;
- Informed consent
Exclusion
- Women with a negative reproductive history, including a history of:
- ① recurrent miscarriage: women with twice and more than twice spontaneous miscarriage, missed abortion, biochemical pregnancies, etc.;
- ② fetal malformation or chromosomal abnormalities;
- ③ intrauterine death.
- Women with a history of one side adnexectomy;
- Women with a poor ovarian response or diminished ovarian reserve (based on Bologna' criteria);
- Women with ovulation dysfunction;
- Women with PCOS (based on Rotterdam's criteria);
- Women with endometriosis;
- Women with the following uterine abnormalities: uterine malformation (unicornuate uterus, uterus bicornis, uterus duplex, mediastinum uterus), adenomyosis, submucosa myoma, intrauterine adhesion;
- Chromosomal abnormality for either or both of the couple;
- Women with contraindications for ART or pregnancy: uncontrolled diabetes mellitus, cardiac disease, undiagnosed liver and/or renal function, vaginal bleeding, suspected or a past history of cervical cancer, endometrial cancer, breast cancer, and a history of deep venous thrombosis, pulmonary embolism, stroke, etc.;
- Women who are enrolled in other clinical trials.
Key Trial Info
Start Date :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
1892 Patients enrolled
Trial Details
Trial ID
NCT03809221
Start Date
February 1 2019
End Date
December 31 2020
Last Update
January 18 2019
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