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Pituitary down regulation is widely used during in vitro fertilization (IVF) procedures. It can suppress the spontaneous luteinizing hormone (LH) surge, and can also make follicles growth evenly.
At present, standard gonadotropin releasing hormone analogue (GnRH-a) long protocol is used in arou Long term GnRH-a, which is usually used in patients with endometriosis,has been shown to increase IVF outcome by altering endometrial receptivity. Moreover, it is also very convenient because patients do not have to inject GnRH-a daily. In order to make patients feel more comfortable during IVF treatment, the investigators have used a new ovarian stimulation protocol since the beginning of 2015. The investigators give patients long term GnRH-a (3.75mg) once at menstrual cycle D2, and begin the use of Gn to stimulate follicle growth around 30 days later based on the hormone levels and follicle size. In the pilot observational study of several patients, no LH surge occurred during ovarian stimulation.
The aim of this randomized controlled study is to compare the efficiency of this new protocol and standard GnRH-a long protocol in the investigator's center.
The primary outcome is clinical prengancy rate. Secondary outcome is cumulative live birth rate. Other parameters include number of oocytes retrieved, 2 pronucleus (2PN) fertilization rate, high quality embryo formation rate, implantation rate, spontaneous abortion rate, and ectopic pregnancy rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New protocol group | Experimental | Use long term GnRH-a 3.75mg at day 2 of menstrual cycle. Around 30 days later, controlled ovarian hyperstimulation using gonadotropins is initiated. |
|
| GnRH-antagonist | Active Comparator | In the GnRH antagonist protocol, Gn was injected from day 2-3 of the menstrual cycle and GnRH antagonist (Cetrotide; 0.25 mg) was added daily from day 6 of stimulation. When 2 dominant follicle ≥ 18 mm or three follicles ≥ 17 mm, recombinant human chorionic gonadotropin (hCG) was injected. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GnRH-a | Drug | In experimental group, patients use long term GnRH-a; Patients' serum or follicle fluid will be collected if needed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| clinical pregnancy rate | 5 weeks after embryo transfer, gestational sac with fetal heart present inside uterus | 5 weeks after embryo transfer |
| Measure | Description | Time Frame |
|---|---|---|
| cumulative live birth rate | 2 years after oocyte retrivial | |
| Number of oocytes retrieved | 1 day at oocyte retrieved day | |
| 2 pronucleus (2PN) fertilization rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yingpu Sun, M.D | Zhengzhou University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reproductive Medical Center, 1st Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 450052 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16437491 | Background | Sallam HN, Garcia-Velasco JA, Dias S, Arici A. Long-term pituitary down-regulation before in vitro fertilization (IVF) for women with endometriosis. Cochrane Database Syst Rev. 2006 Jan 25;2006(1):CD004635. doi: 10.1002/14651858.CD004635.pub2. | |
| 24006906 | Background | Niu Z, Chen Q, Sun Y, Feng Y. Long-term pituitary downregulation before frozen embryo transfer could improve pregnancy outcomes in women with adenomyosis. Gynecol Endocrinol. 2013 Dec;29(12):1026-30. doi: 10.3109/09513590.2013.824960. Epub 2013 Sep 5. |
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| ID | Term |
|---|---|
| C090784 | ricin A-GnRH conjugate |
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| GnRH-anta | Drug | In control group, patients use GnRH-antagonist. Patients' serum or follicle fluid will be collected if needed. |
|
Number of 2PN/Matured oocytes |
| 48 hours after oocyte retrieved day |