Subfertility, Female, Ovulation Disorder
Conditions
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.
Interventions
DRUGDiphereline (Triptorelin embonate)
DRUGDecapeptyl (Triptorelin)
DRUGhuman chorionic gonadotropin
Sponsors
Navy General Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| multiple pregnancy | 3 years | The condition of carrying two or more FETUSES. |
| 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. |
| Number of embryos obtained | 3 years | — |
| miscarriage | 3 years | Expulsion of the product of FERTILIZATION before completing the term of GESTATION and without deliberate interference. |
Countries
China
Contacts
Primary ContactWei Shang, Dr
Outcome results
None listed