Female Infertility
Conditions
Keywords
Hormonal monitoring; Frozen embryos; Progesterone; estradiol
Brief summary
Hormonal monitoring impact on overall pregnancy rate in frozen embryo transfer (FET)cycles and hence progesterone supplement adjustments remain debatable in current literature. This prospective randomized study aims to investigate the effect of monitoring and follow-up of serum progesterone, estradiol & luteinizing hormone (LH) levels and progesterone supplement adjustments on pregnancy outcomes for FET in programmed hormonal replacement therapy cycles in comparison with ultrasound only in control group
Detailed description
Progesterone (P4) is a steroidal hormone that is required for successful embryo implantation and maintenance of the pregnancy in natural cycles, fresh in vitro fertilization cycles, and frozen embryo transfer (FET) cycles. Women undergoing FET in programmed cycle are unable to provide adequate endogenous P4 and require progesterone supplementation to initiate and maintain the secretory endometrium and pregnancy. There has been previous research into luteal phase support in frozen cycles, which has demonstrated that supplementation of progesterone does impact outcome in FET. Despite this evidence for the role of progesterone, there is surprisingly little data on the optimal values for serum P4 during the luteal phase and specifically on the day of embryo transfer in frozen cycles. Following years of a prevalent belief that the higher values of P4 are better, it seems that there may be an optimal window for P4 values during the luteal phase in bovine IVF. Though progesterone levels on the day of transfer have not yet been studied extensively in humans, tailoring the time of transferring a frozen embryo based on serial P4 values rather than cycle day number alone results in higher pregnancy rates. By direct action on the endometrium, a rise of LH might interfere with endometrial receptivity during a FET cycle, in which no pituitary suppression is used. The significance of LH level on the day before addition of progesterone is not yet well defined. The aim of this study is to investigate the effect of monitoring and follow-up of serum progesterone, estradiol & luteinizing hormone levels on day of embryo transfer on pregnancy outcomes for FET in programmed HRT cycles in comparison with ultrasound only in control group and to evaluate the effect of progesterone supplements adjustments depending on serum progesterone levels on day of FET in affecting clinical pregnancy rate.
Interventions
DRUGestradiol valerate
8mg orally on daily basis for 13 days beginning with the first day of either a spontaneously or induced menstrual cycle then assess by ultrasound
OTHERHormonal monitoring progesterone, estradiol, luteinizing hormone
Serum Progesterone, estrogen & LH measured on day 13 after priming endometrium with 8mg estradiol valerate on a daily basis beginning as early as the first day of menstrual cycle.
DIAGNOSTIC_TESTtransvaginal ultrasound examination
Patients examined using transvaginal ultrasonography on day 13 of exogenous estrogen supplementation to measure endometrial thickness and to detect signs of escape ovulation
DRUGProgesterone 400 Mg Vaginal Suppository
Progesterone supplements given in form of daily two vaginal prontogest suppositories400 mg each
OTHERHormonal monitoring progesterone and estradiol
Measuring the serum Progesterone & Estradiol in the early morning on the day of embryo transfer an progesterone supplementation adjusted as follows: Group II A: If P4 levels \< 5ng/dl, one 100 mg intramuscular injection daily added, Group II B: If P4 levels 5-10ng/dl, dydrogesterone three times daily added. Group II C: If P4 levels \>10ng, continued on 400 mg prontogest suppositories twice daily
DRUGProgesterone
group II A: 100 mg intramuscular injection daily Group II B: If P4 levels 5-10ng/dl dydrogesterone added
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 42 Years
Healthy volunteers
No
Inclusion criteria
1. Age of female patient 42 years or less 2. Normal uterine cavity 3. All embryos are day 5 or day 6 frozen blastocysts
Exclusion criteria
1. History of recurrent implantation failure 2. Previously known major thrombophilia factors 3. Non-compliance to given protocol 4. Endometrial thickness \< 7mm after 13 days of priming with estradiol valerate 5. pre-existing metabolic diseases (Diabetes Mellitus & Hypertension).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| live birth rate | assessed 26-40 weeks after embryo transfer | the number of live births (defined as at least one live born after 28 weeks of gestation) divided by the total number of patients who performed pregnancy tests |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| clinical pregnancy rate | assessed 4 weeks after embryo transfer | the number of clinical pregnancies (defined as the presence of a gestational sac with positive heart beat detected by transvaginal ultrasound scan 2 weeks after positive pregnancy test) divided by the number of embryo transfer procedures |
Countries
Egypt
Outcome results
None listed