infertility
Conditions
Interventions
intervention group:early follicular phase full-dose down-regulation controlled ovarian hyperstimulation
placebo group:luteal phase down-regulation controlled ovarian hyperstimulation
Sponsors
Peking university People's Hospital
Eligibility
Sex/Gender
Female
Age
20 Years to 38 Years
Inclusion criteria
Inclusion criteria: 1. Women aged between 20 to 38 years old and with a history of infertility (failing to get pregnant after over one years 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; 2. Women who start their first IVF/ICSI cycle; 3. Women with a normal ovarian reserve tests results 6 months before recruiting according to: (1) basal steroid hormone on day 2-4 of menstrual cycle: basal FSH=10mIU/ml, estradiol (E2) <50pg/ml; (2) anti-Müllerian hormone (AMH)=1.1ng/ml; (3) antral follicle count (AFC) =7; 3. Women who start their first IVF/ICSI cycle; 4. Women who have given the informed consent.
Exclusion criteria
Exclusion criteria: 1. 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. 2. Women with a history of one side adnexectomy; 3. Women with a poor ovarian response or diminished ovarian reserve (based on Bologna' criteria); 4. Women with ovulation dysfunction; 5. Women with PCOS (based on Rotterdam's criteria); 6. Women with endometriosis; 7. Women with the following uterine abnormalities: uterine malformation (unicornuate uterus, uterus bicornis, uterus duplex, mediastinum uterus), adenomyosis, submucosa myoma, intrauterine adhesion; 8. Chromosomal abnormality for either or both of the couple; 9. 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.; 10. Women who are enrolled in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| live birth rate per transferred cycle; | — |
Secondary
| Measure | Time frame |
|---|---|
| live birth rate per stimulated cycle;cumulative live birth rate;time to pregnancy;clinical pregnancy rate;biochemical pregnancy rate;continuous pregnancy rate;the number of retrieved oocyte;the number of MII oocyte;the thickness of endometrium on hCG day;estradiol on hCG day;progesterone on hCG day;LH on hCG day;incidence of moderate to severe OHSS;pregnancy loss rate;pregnancy complications;adverse outcomes of fetus and neonates; | — |
Countries
China
Contacts
Public ContactLi Jiang
Peking University People's Hospital
Outcome results
None listed