Female Infertility, Infertility, Pregnancy Early
Conditions
Keywords
Hormone replacement therapy, Frozen thawed embryos, Frozen embryo cycle
Brief summary
Investigators will be comparing artificial (HRT) frozen-thawed embryo transfer cycles to correctly conducted spontaneous natural cycles after the transfer of a chromosomally normal embryo.
Detailed description
The most common treatment protocols for frozen embryo transfers include natural cycles with or without human chorionic gonadotrophin (HCG) trigger or endometrial preparation with hormonal treatment (artificial cycles), with or without Gonadotrophin - releasing hormone agonist suppression. Recent studies comparing artificial and natural cycles concluded that the optimal means of endometrial preparation for frozen- thawed cycle remains unclear and both options may be offered to women with regular ovulatory cycles. Correctly identified spontaneous natural cycles are the preferred option for frozen-thawed embryo transfer in women with regular menstrual cycles. Investigators will be comparing artificial (HRT) frozen-thawed embryo transfer cycles to correctly conducted spontaneous natural cycles after the transfer of a chromosomally normal embryo.
Interventions
None listed
Sponsors
ART Fertility Clinics LLC
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
Yes
Inclusion criteria
include the following: 1. Women aged 18 years to 42 years with regular menses (26-34 days) 2. Having 1 or 2 chromosomally normal cryopreserved blastocysts available for transfer. 3. First frozen-thawed transfer cycle 4. Progesterone level \< 1.5 ng/mL day of trigger injection in stimulation cycle from which embryos to be transferred were created.
Exclusion criteria
include the following: 1. Polycystic ovarian syndrome 2. Poor ovarian responder in accordance with Bologna criteria 3. Uterine abnormality US / saline infusion sonohysterogram 4. Previous dilatation & curettage (D&C) 5. Hydrosalpinx 6. Asherman syndrome 7. History of endometriosis 8. ICSI due to severe male factor with testicular sperm 9. Any known contraindications or allergy to oral estradiol or progesterone. 10. Discontinuation of HRT medication ( medication error in research HRT cycle ) 11. Failure to detect ovulation in the research natural cycle 12. Duration of estradiol exposure ≥ 17 days and endometrium \< 6mm 13. Spontaneous ovulation in HRT artificial cycle
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ongoing pregnancy rate to 8 weeks gestation | 8 weeks | viable pregnancy to 8 gestational weeks |
| Pregnancy rate beta human chorionic gonadotropin (ß-hCG) > 5 IU | 12 days | Number of patients with a hCG \> 5 IU out of the number of patients who underwent an embryo transfer with one or two euploid embryos |
| Biochemical pregnancy rate | 5 weeks | Positive ß-hCG, but at 5 gestational weeks no ultrasonographic visible gestational sac seen |
| Clinical implantation rate | 6 weeks | Number of gestational sacs observed by ultrasound at 6 weeks of gestation divided by the number of embryos transferred |
| Clinical pregnancy rate | 5 weeks | Ultrasonographic visible sac at 5 gestational weeks |
Countries
United Arab Emirates
Outcome results
None listed