IVF
Conditions
Keywords
IVF-Fresh ET-FET-clinical pregnancy
Brief summary
The objective of our study is to compare in vitro fertilization (IVF) outcomes between fresh embryo transfer (ET) and frozen-thawed ET in women with polycystic ovary syndrome (PCOS).
Detailed description
Eligible women will be randomized to two groups in a ratio of 1:1 . Both the patients and the clinicians will be aware of the allocated arm. The patients (110) will be equally randomized into two groups: Group A will undergo a day 3 fresh embryo transfer after ovarian stimulation, luteal phase support will be started just after follicular aspiration. Group B will have all of their embryo cryopreserved after ovarian stimulation with no luteal phase support after the aspiration and then undergo a frozen-thawed day 3 embryo transfer. Controlled ovarian stimulation will be done using the gonadotropin releasing hormone (GnRH) antagonist protocol then human chorionic gonadotropin( HCG) 5000 IU trigger for final oocyte maturation.
Interventions
PROCEDUREfresh embryo transfer
55 patients undergoing fresh embryo transfer after ovarian stimulation followed by luteal phase support
PROCEDUREFrozen embryo transfer
55 patients undergoing frozen embryo transfer after ovarian stimulation followed by cryopreservation of all embryos and transfer in another cycle.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Group 1; Fresh embryo transfer in PCO patients Group 2: Frozen ET in PCO patients
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Women diagnosed with PCOS according to modified Rotterdam criteria which includes menstrual abnormalities combined with either hyperandrogenism (hirsutism diagnosed by modified Ferriman-Gallwey score or elevated total testosterone level) or polycystic ovaries. * Women ages ≥20 and \<40years old. * BMI less than 35. * Women who have a history of infertility. * All patients will receive adjuvant drugs for ovulation induction (metformin from preceding cycle, cabergoline 1 tab daily for 8 days and 500 cc colloid solution on day of ovum pick up).
Exclusion criteria
* History of unilateral oophorectomy. * Uterine abnormalities such as a malformed uterus (unicornuate, septate uterus), adenomyosis, submucous myoma or intrauterine adhesion. * Severe male factor for infertility such as azoospermia. * History of repeated ICSI trials failure. * Women who are unable to comply with the study procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical pregnancy rate | 35 days after embryo transfer | Transvaginal Ultrasound to detect gestational sac(GS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chemical pregnancy rate | 14 days after embryo transfer. | Serum β-human chorionic gonadotropin (HCG) will be measured to determine pregnancy after embryo transfer. |
| Early ovarian hyperstimulation syndrome rate(OHSS rate) | 3 days after follicular aspiration | Abdominal ultrasound ,Hematocrit |
| Ectopic pregnancy rate | 14 days for BHCG , vaginal US 3 weeks after transfer | BHCG then doubling after 48 hours ,vaginal ultrasound |
Countries
Egypt
Contacts
Primary ContactMarwa Mo Eid, Ass.prof
Backup ContactAbdullah S ha, Ass.Lecturer
Outcome results
None listed