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The Effect of Sildenafil Citrate on Frozen Embryo Transfer Cycles

The Effect of Sildenafil Citrate on the Endometrial Thickness and Pregnancy Rates of Frozen Embryo Transfer Cycles

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05951413
Enrollment
110
Registered
2023-07-19
Start date
2023-06-30
Completion date
2023-09-30
Last updated
2023-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IVF

Keywords

Sildenafil, thawed embryo transfer, endometrial thickness

Brief summary

to investigate the value of adding sildenafil citrate during endometrial preparation in patients undergoing frozen-thawed embryo transfer and its effect on endometrial thickness and pregnancy rates.

Detailed description

Patients who met these conditions entered the study and 110 patients will be divided into two groups 55 patients in each group based on randomized tables. Group 1: will be given estradiol in form of Cycloprogynova white pills starting dose is one pill t.i.d may be increased to two pills t.i.d according to endometrial thickness in day 9 measured by vaginal ultrasound. Group 2: will be given sildenafil citrate tablets (50 mg) daily in addition to the above treatment protocol from the first day of the cycle until the day of starting progesterone. It was discontinued 48- 72 hours prior to the embryo transfer. On the ninth day of the menstrual cycle, the endometrial thickness will be estimated by transvaginal ultrasonography (arranged in a series every other day). The evaluations will be performed by a single investigator. If the endometrial thickness was more than 8mm, 400 mg of progesterone vaginal suppository and Duphastone tabs twice daily will be administered. If the endometrial thickness is less than 8 mm estrogen dosage will be increased to two pills t.i.d and patients would be arranged for follow up every other day for endometrial thickness estimation by transvaginal ultrasound till endometrial thickness is more than 8 mm , then 400 mg of progesterone vaginal suppository and Duphastone tabs twice daily will be administered. Frozen thawed embryo transfer will be carried out after 5 days (blastocyst stage). Estrogen and progesterone will be continued until two weeks after the embryos are transferred. In cases whom BHCG would be positive, estrogen and progesterone will be continued until the 11th week of pregnancy.

Interventions

DRUGSildenafil Citrate

a potent and selective inhibitor of cGMP-specific phosphodiesterase type 5 (PDE5),

DRUGestradiol

estradiol in form of Cycloprogynova white pills starting dose is one pill t.i.d may be increased to two pills t.i.d according to endometrial thickness in day 9 measured by vaginal ultrasound.

Sponsors

Beni-Suef University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

1. Age under 40 years 2. Subject has high quality frozen embryos

Exclusion criteria

1-A history of endocrine diseases. 2. A history of any previous surgery that could compromise the integrity of endometrium. 3\. Cardiovascular, renal and liver diseases. 4. Hypotension (blood pressure less than 90/50). 5. A history of stroke or myocardial infarction. 6. A history of previous implantation failure.

Design outcomes

Primary

MeasureTime frameDescription
endometrial thickness10 to 16 days from start of cycleendometrial thickness measured by transvaginal ultrasound

Secondary

MeasureTime frameDescription
pregnancy rate1 monththe number of patients who get pregnant measured by HCG test positive

Countries

Egypt

Contacts

Primary ContactSara A Salem, MD
sara_abdallah100@yahoo.com01272842226

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026