Pregnancy Related, Infertility, Female
Conditions
Keywords
implantation rate, infertility, pregnancy rate, natural cycle, luteal phase support, live birth, progesterone
Brief summary
To evaluate whether single euploid embryo transfer in NC without routinely administered LPS is non-inferior to NC with routinely administered LPS.
Detailed description
In case the study will show that the live birth rate in single euploid NC frozen embryo transfer cycles without LPS is not inferior to NC cycles with LPS, treatment can be simplified, and participants comfort can be increased.
Interventions
DIAGNOSTIC_TESTTransvaginal ultrasound
Intermittent transvaginal ultrasound throughout the cycle to monitor follicular growth
DIAGNOSTIC_TESTSerial serum LH, E2, P4
Serial measurements of serum Luteinizing Hormone (LH), Estradiol (E2) and Progesterone (P4 )levels throughout the cycle to determine ovulation. LH-surge is identified when a rise of 180% above the previous level occurred and ovulation is confirmed with a decrease in E2 concentration, and a rise of progesterone level to ≥ 1.0 ng/ml (Irani et al., 2017).
On day of ET procedure, to administer 200 mg of vaginal progesterone and increase to 300 mg/day from the day after the ET onwards until the pregnancy test. In case of an implantation, vaginal P4 will be continued until 7 weeks of pregnancy
DIAGNOSTIC_TESTSerum P4 day of ET - Control Group
Serum P4 will be drawn before starting LPS in form of vaginal progesterone on the day of ET procedure
DIAGNOSTIC_TESTSerum P4 day of ET - Study Group
Serum P4 will be drawn when study group participants are admitted to the clinic for the ET procedure.
PROCEDUREEmbryo transfer
The procedure in which embryo is placed in the uterus.
DIAGNOSTIC_TESTSerum hCG 10 days after ET
Pregnancy will be confirmed / excluded by measurement of serum hCG 10 days after ET procedure and a level of \> 15 IU will be regarded as positive result. The definitions of biochemical, ectopic, clinical and ongoing pregnancy follow the ICMART criteria (Zegers-Hochschild, 2006)
DIAGNOSTIC_TESTSerum P4 10 days after ET
Serum P4 will be drawn on day 5 or day 6 after the ET procedure and together with the hCG 10 days after ET procedure
Sponsors
ART Fertility Clinics LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Age: 18 to 40 years * Regular ovulatory cycles * Availability of at least one euploid embryo after Trophectoderm biopsy for PGT-A on day 5 or day 6 * Detection of ovulation by P4 rise \> 1.0 ng/ml after LH surge * P4 value of at least 5 ng/ml on day 4 after ovulation
Exclusion criteria
* History of repeated pre-menstrual spotting * Factors affecting the implantation through anatomical changes of the uterus / ovaries or the tubes (adenomyosis, Asherman syndrome, endometriosis, uterine fibroids / polyps, isthmocele with intracavitary fluid presence, hydrosalpinx….)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum E2 and P4 levels on day 10 after ET procedure | 10 days | Estradiol and Progesterone levels on day 10 after embryo transfer |
| Serum P4 levels on ET day | 1 day | Progesterone level on the day of embryo transfer |
| Serum E2 and P4 levels on day 5 or 6 after ET procedure | 6 days | Estradiol and Progesterone levels on day 5 or 6 after embryo transfer |
| Implantation rate | 2 months | Number of embryos which have produced ultrasonographic evidence of an intrauterine gestational sac per the total number of embryos transferred into the uterine cavity (Zegers-Hochschild et al., 2009). |
| Clinical pregnancy rate | 2 months | hCG \> 15 Iu/ml and ultrasound confirmation of a gestational sac |
| Live birth rate | 41 weeks | Number of deliveries that resulted in a live born neonate, expressed per 100 embryo transfers (Zegers-Hochschild et al., 2009) |
Countries
United Arab Emirates
Contacts
Primary ContactBarbara Lawrenz, PhD
Backup ContactJonalyn Edades, RN
Outcome results
None listed