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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose GnRHa | Experimental | 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. |
|
| GnRHa Ultra-short Protocol | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diphereline (Triptorelin embonate) | Drug |
| ||
| Decapeptyl (Triptorelin) |
| Measure | Description | Time Frame |
|---|---|---|
| live birth | 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). | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| clinical pregnancy rate | Presence of fetal heart at transvaginal ultrasound at 6 weeks of gestation or 6 weeks after starting the intervention. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| multiple pregnancy | The condition of carrying two or more FETUSES. | 3 years |
| miscarriage | Expulsion of the product of FERTILIZATION before completing the term of GESTATION and without deliberate interference. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Shang, Dr | Contact | shang.wei@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Wei Shang, Dr | Navy General Hospital, Beijing | Principal Investigator |
| Yunhai Chuai, Dr | Navy General Hospital, Beijing | Principal Investigator |
| Mingming Shu, Dr |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Navy General Hospital | Beijing | Beijing Municipality | 100048 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39783453 | Derived | Siristatidis CS, Yong LN, Maheshwari A, Ray Chaudhuri Bhatta S. Gonadotropin-releasing hormone agonist protocols for pituitary suppression in assisted reproduction. Cochrane Database Syst Rev. 2025 Jan 9;1(1):CD006919. doi: 10.1002/14651858.CD006919.pub5. |
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| Drug |
|
| human menopausal gonadotropin | Drug |
|
| human chorionic gonadotropin | Drug |
|
| 3 years |
| Ectopic pregnancy | 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). | 3 years |
| 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 | 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). | 3 years |
| Congenital Abnormalities | Malformations of organs or body parts during development in utero. | 3 years |
| 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 | Principal Investigator |
| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D007246 | Infertility |
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| ID | Term |
|---|---|
| D017329 | Triptorelin Pamoate |
| D008596 | Menotropins |
| D006063 | Chorionic Gonadotropin |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D006065 | Gonadotropins, Pituitary |
| D006062 | Gonadotropins |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D010926 | Placental Hormones |
| D011257 | Pregnancy Proteins |
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