ClinicalTrials.gg
CompletedNCT04114500FETUpdated Jul 8, 2020

The Association Between Serum E2 and P on the Day of FET and the Pregnancy Outcome

An observational study in Frozen Embryo Transfer, sponsored by Al Baraka Fertility Hospital. Completed at 1 site in Bahrain. Open to female participants aged 22 Years to 40 Years. Per ClinicalTrials.gov, last updated 2020-07-08.

Sponsored by Al Baraka Fertility Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
402
Ages
22 Years to 40 Years
Sex
Female
01

Study summary

The outcomes of frozen embryo transfer (FET) have substantially improved over the last decade, due to the improvements in the cryopreservation process, Artificial endometrial preparation is typically accomplished by the administration of estradiol (E2) supplementation and exogenous progesterone (P) in order to transform the endometrium into a secretory one, mimicking a natural cycle , The current study aims to determine the association, if any, between serum E2 and P levels, measured same day of FET, and pregnancy outcome

Read the detailed description

Study design a retrospective cohort study for 402 FET cycles which will be conducted in Al- Baraka Fertility Hospital, Manama, Bahrain, between April 2018 and May 2019. The trial registration number for the study is (NCT04114500), and it was approved by our ethical committee Study population

  • Inclusion criteria were women who underwent FET, were age below 40 yrs., body mass index (BMI) below 30 kg/m2, patients who underwent FET treatment using the endometrial preparation was initiated with oral estradiol valerate, the endometrial thickness was no less than 8 mm on the day when P was administrated; with normal endometrial ultrasound imaging and euploid pre-genetically tested embryos;
  • Exclusion criteria were chromosomal and genetic disorders, age> 40 years, BMI > 35 , abnormal ultrasonogram of uterine cavity (acquired or congenital) and abnormal embryos not suitable for transfer.

Study protocol Endometrial preparation in frozen embryo transfer (FET) briefly, patients received treatment with 2 mg/8h E2 (Estrofem, Novo Nordisk) for 12-14 days, Endometrial thickness was evaluated with transvaginal sonography. When endometrial thickness reached 8 mm or greater and was trilaminar in appearance, patients were initiated on both vaginal micronized P (Crinone gel, Merck) and oral P (Duphastone, Abott) treatment at 200 mg/8h. P4 was given as supplementation because normal ovarian steroid production and the ovarian follicular-to-luteal transition were suppressed with estradiol. A depot GnRH agonist was administered in the midluteal phase of the preceding cycle at clinician's discretion. On the early morning of day 5 of P treatment, the same day of FET, a blood sample was obtained and immediately analyzed. Hormone determinations of E2 and P were performed. Then, embryo transfer of the pre-genetically tested euploid embryos was performed under ultrasound guidance. 12 days later pregnancy test was assessed, 4 weeks after FET date ultrasound will be scheduled to check the viability and clinical pregnancy.

02

Conditions studied

  • Frozen Embryo Transfer

Keywords

  • Estradiol
  • FET
  • IVF
  • Progesterone
03

In context

Lead sponsor

Al Baraka Fertility Hospital is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years to 40 Years
Sexes eligible
Female
Sampling method
Probability sample

Study population

Patients undergoing IVF/FET were recruited from April 2018 to September 2019.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients who underwent frozen-thawed embryos transfer treatment
  • the endometrial preparation was initiated with oral estradiol valerate
  • the endometrial thickness was no less than 8 mm on the day when P was administrated;
  • normal endometrial ultrasound imaging
  • euploid pre-genetically tested embryos

Exclusion criteria

Exclusion Criteria:

  • age> 40 years
  • > 35
  • abnormal ultrasonogram of uterine cavity
  • abnormal embryos not suitable for transfer
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
402 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testserum estradiol and progesterone

    blood sample for measuring serum estradiol and progesterone level on the same day of FET

06

What researchers measure

Primary outcomes

  1. Pregnancy rate

    B-hCG

    Time frame: 2 weeks

  2. clinical pregnancy rate

    positive fetal heart beat

    Time frame: 4 weeks

07

Study locations

1 site
  • Al-BARAKA FERTILITY HOSPITAL
    Manama, Adliya 15006, Bahrain
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04114500
Lead sponsor
Al Baraka Fertility Hospital
Responsible party
Dr. Kamal Rageh (doctor , medical director, Al Baraka Fertility Hospital) — Principal investigator
First posted
Oct 3, 2019
Start date
Apr 3, 2018
Primary completion
May 1, 2019
Completion
May 5, 2019
Last update
Jul 8, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion