Infertility, Female, Intrauterine Adhesion
Conditions
Brief summary
Evaluation of endometrial preparation using either human menopausal gonadotrophin (HMG) stimulation and hormone replacement therapy (HRT) prior to blastocyst transfer in patients with moderate to severe intrauterine adhesion (IUA).
Interventions
DRUGhuman menopausal gonadotrophin
experimental group:Women will be given HMG 37.5-150IU daily followed by monitoring of the follicular growth (folliculometry) when serum Estradiol (E2)\<100pg/ml，progesterone (P)\<1ng/ml. Final oocyte maturation will be induced by administration of human chorionic gonadotropin (HCG) when there will be at least one leading follicle ≥20mm in diameter followed by luteal phase support (using progesterone supplements) after 24 hours.
DRUGhormone replacement therapy
Women will be given 17 β-estradiol hemihydrate 2 mg and estrogen gel 5 g daily from day 3 of the cycle then the endometrial thickness will be assessed on day 7 by transvaginal sonography (TVS). If the endometrium is ≥ 9 mm, luteal phase support (using progesterone supplements) will be started but if the endometrium is \< 9 mm, estradiol will be continued until reaching appropriate endometrial thickness and then the luteal phase support will be started. The cycle will be cancelled If the estradiol administration \>60 days.
Sponsors
Reproductive & Genetic Hospital of CITIC-Xiangya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* BMI 18\ 23 kg/m2 * Women with moderate to severe IUA as defined by the American Fertility Society classification (1988) * Presence of at least 3 cryopreserved cleavage-stage embryos (including 1 good quality) or blastocysts
Exclusion criteria
* Using embryos from donor oocytes * Preimplantation genetic diagnosis(PGD)/Preimplantation genetic screening(PGS) cycles * Moderate or severe endometriosis * Untreated unilateral or bilateral hydrosalpinx * Uterine adenomyosis, uterine myoma (submucous,intramural myoma \>4 cm),\>1cm septate uterus, double uterus, bicornuate uterus, unicornuate uterus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ongoing pregnancy rate | 10th week after embryo transfer | Ongoing pregnancy is defined as the presence of a gestational sac with foetal heartbeat by transvaginal ultrasound at 10th week after embryo transfer（ET） |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cycle cancellation rate | the day of embryo transfer | — |
| Implantation rate | 4th weeks after embryo transfer | Sacs seen in early ultrasound divided by the number of embryos transferred |
| Clinical pregnancy rate | 4th weeks after embryo transfer | Number of patients with ultrasound evidence of pregnancy divided by the number of embryo transfers |
| Early miscarriage rate | 12th weeks gestational age | Number of losses of clinical pregnancies divided by number of clinical pregnancies |
| Biochemical pregnancy rate | 4th weeks after embryo transfer | number of pregnancies with a transient elevation of serum human chorionic gonadotropin(β-hCG) level (\>10 mIU/ml) divided by number of embryo transfers |
Countries
China
Outcome results
None listed