Infertility
Conditions
Keywords
infertility froze emberyo transfer hormone replacement
Brief summary
This study is a prospective randomized controlled trial to compare the pregnancy outcomes of frozen embryo transfer in natural and hormonal replacement cycles. The study population consisted of all infertile women with regular menstrual cycles who will undergo IVF/ICSI and frozen embryo transfer in Reproductive Biomedicine Research Center, Royan institute, Tehran Iran.
Detailed description
In this study all patients who will undergo frozen embryo transfer are randomly allocated to be prepared for transfer by using either natural cycle (with or without hCG for ovulation induction) or Hormonal cycle (with or without administration of GnRH-a) In natural cycle without hCG, daily monitoring of urinary LH is started from day eight of the cycle and frozen-thawed embryo transfer is planned 3-5 days after detection of LH surge, observing mature follicles in ultrasound and endometrial thickness over 7mm for cleavage embryos. In natural cycle with hCG, after detection of mature follicles in ultrasound and endometrial thickness over 7mm, 10,000IU hCG is injected for ovulation and embryo transfer is performed 3-5 days later in cleavage stage. In group 3, injection of GnRH agonist (Superfact) at a subcutaneous daily dose of 0.5 mg is started on the day 17-19 of the natural menstrual cycle. Once pituitary desensitization is confirmed, hormonal treatment is commenced with 4mg/day oral Estradiol valerate and after 7 days if endometrial thickness is adequate, Estradiol administration will be continued with the same dose and 100mg Progesterone is administered before embryo transfer, otherwise patients are candidates for higher dosage of Estradiol till favourable endometrial thickness is achieved. In the hormonal group without GnRH-a, endometrial preparation will be started with daily administration of 6 mg Estradiol valerate from the 2nd day of the natural menstrual cycle for 6 days. Then treatment will be continued similar to the 3rd group.
Interventions
BIOLOGICALfrozen Embryo transfer
In this study all patients who will undergo frozen embryo transfer are randomly allocated to be prepared for transfer by using either natural cycle (with or without hCG for ovulation induction) or Hormonal cycle (with or without administration of GnRH-a).
DRUG10,000U hCG injection
In natural cycle with hCG, after detection of mature follicles in ultrasound and endometrial thickness over 7mm, 10,000IU hCG is injected for ovulation and embryo transfer is performed 3-5 days later in cleavage stage.
DRUGGnRH agonist (Superfact)
In group 3, injection of GnRH agonist (Superfact) at a subcutaneous daily dose of 0.5 mg is started on the day 17-19 of the natural menstrual cycle. Once pituitary desensitization is confirmed, hormonal treatment is commenced with 4mg/day oral Estradiol valerate and after 7 days if endometrial thickness is adequate, Estradiol administration will be continued with the same dose and 100mg Progesterone is administered before embryo transfer, otherwise patients are candidates for higher dosage of Estradiol till favourable endometrial thickness is achieved.
DRUGadministration of 6 mg Estradiol valerate
In the hormonal group without GnRH-a, endometrial preparation will be started with daily administration of 6 mg Estradiol valerate from the 2nd day of the natural menstrual cycle for 6 days. Then treatment will be continued similar to the 3rd group.
Sponsors
Royan Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 37 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with regular mensturation cycles 2. Age 20-37 years 3. Patients who underwent long protocol 4. Body mass index (BMI) ≤ 30 kg/m2 5. Patients who will undergo frozen embryo transfer for the first time
Exclusion criteria
1. Oocyte or embryo donation cycles 2. Uterine diseases or malformations 3. Hyper prolactinemia 4. Thyroid disorders 5. Tuberculosis 6. Recurrent abortion history 7. Severe endometriosis 8. Ovulation disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical pregnancy rate | 4 weeks | The pregnancy rate will be evaluated in patients of each groups 4-6 weeks after embryo transfer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implantation rate | 4 weeks | Evaluation the implantation rate in patients of each groups 4-6 weeks after frozen embryo transfer |
| chemical pregnancy rates | 2 weeks | Evaluation the chemical pregnancy rates in patients of each group 2 weeks after embryo transfer. |
| Ongoing pregnancy | 12 weeks | Evaluation the ongoing pregnancy in patients of each group 12 weeks after embryo transfer. |
| miscarriage rate | 12 weeks | Evaluation the miscarriage rate in patients of each group 12 weeks after embryo transfer. |
Countries
Iran
Contacts
Primary ContactNasser Aghdami, MD,PhD
Backup ContactLeila Arab, MD
Outcome results
None listed