Low Dose GnRHa Early Luteal Phase Down Regulation Versus GnRHa Ultra-short Protocol for Poor Ovarian Response
Study Details
Study Description
Brief Summary
The management of the poor responder patients is very difficult. Currently, there is no any standard treatment for poor responder patients. The study is designed to test a modified GnRHa protocol for poor ovarian response, low dose GnRHa early luteal phase down regulation, compare with GnRHa ultra-short protocol. This is a randomized controlled trial.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Low Dose GnRHa Diphereline 0.375mg was administered in the early-luteal-phase. Human menopausal gonadotropin/human chorionic gonadotropin (HMG/HCG) was administered start in the day 28. |
Drug: Diphereline (Triptorelin embonate)
Drug: human menopausal gonadotropin
Drug: human chorionic gonadotropin
|
| Active Comparator: GnRHa Ultra-short Protocol Decapeptyl 0.1mg was administered in the menstrual day 2 to 7. Human menopausal gonadotropin/human chorionic gonadotropin (HMG/HCG) was administered start in the menstrual day 2. |
Drug: Decapeptyl (Triptorelin)
Drug: human menopausal gonadotropin
Drug: human chorionic gonadotropin
|
Outcome Measures
Primary Outcome Measures
- live birth [3 years]
The event that a FETUS is born alive with heartbeats or RESPIRATION regardless of GESTATIONAL AGE. Such liveborn is called a newborn infant (INFANT, NEWBORN).
Secondary Outcome Measures
- clinical pregnancy rate [3 years]
Presence of fetal heart at transvaginal ultrasound at 6 weeks of gestation or 6 weeks after starting the intervention.
Other Outcome Measures
- multiple pregnancy [3 years]
The condition of carrying two or more FETUSES.
- miscarriage [3 years]
Expulsion of the product of FERTILIZATION before completing the term of GESTATION and without deliberate interference.
- Ectopic pregnancy [3 years]
A potentially life-threatening condition in which EMBRYO IMPLANTATION occurs outside the cavity of the UTERUS. Most ectopic pregnancies (>96%) occur in the FALLOPIAN TUBES, known as TUBAL PREGNANCY. They can be in other locations, such as UTERINE CERVIX; OVARY; and abdominal cavity (PREGNANCY, ABDOMINAL).
- Dose of HMG required [3 years]
- Duration of HMG stimulation [3 years]
- Number of oocytes retrieved [3 years]
- Number of embryos obtained [3 years]
- Number of embryos frozen [3 years]
- Adverse effects [3 years]
According to the Common Terminology Criteria for Adverse Events, version 4.0 (CTCAE 2009). Some adverse events will be studied as separate outcomes, including ovarian hyperstimulation syndrome (OHSS).
- Congenital Abnormalities [3 years]
Malformations of organs or body parts during development in utero.
Eligibility Criteria
Criteria
Inclusion Criteria:
- At least two of the following three features must be present: i. Advanced maternal age (≥40 years) or any other risk factor for POR (poor ovarian response); ii. A previous POR (≤3 oocytes with a conventional stimulation protocol); iii. An abnormal ovarian reserve test (i.e. AFC <7 follicles or AMH <1.1 ng/ml).
Exclusion Criteria:
-
Contraindications for IVF/ICSI
-
Contraindications for pregnancy
-
Primary ovarian insufficiency
-
AFC <3
-
PGD/PGS
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Navy General Hospital | Beijing | Beijing | China | 100048 |
Sponsors and Collaborators
- Navy General Hospital, Beijing
Investigators
- Principal Investigator: Wei Shang, Dr, Navy General Hospital, Beijing
- Principal Investigator: Yunhai Chuai, Dr, Navy General Hospital, Beijing
- Principal Investigator: Mingming Shu, Dr, Navy General Hospital, Beijing
- Principal Investigator: Ming Zhou, Dr, Navy General Hospital, Beijing
- Principal Investigator: Huiming Han, Dr, Navy General Hospital, Beijing
- Principal Investigator: Mengnan Chen, Dr, Navy General Hospital, Beijing
- Principal Investigator: Lei Chen, Navy General Hospital, Beijing
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SW001