Effect of Vaginal Sildenafil Citrate on Endometrial Preparation and Outcome in Frozen Thawed Embryo Transfer Cycles

NCT ID: NCT03854175

Last Updated: 2019-02-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-28
• Study Completion Date: 2020-01-31

Brief Summary

A total of 80 Patients who meet these conditions will enter the study and be divided into two groups based on randomized tables.

To prepare the endometrium,

Group A : 40 women are given oral estradiol valerate tablets 2mg 6-8 hourly from the day 2-14 of the cycle to prepare the endometrium

Group B : 40 women are give sildenafil citrate 25mg vaginally every 6 hours (a half of 50 mg tablet is crushed and dissolved in 2cc of distilled water and injected in to vagina) starting from day 2-14 of the cycle, in addition to oral 2mg of estradiol valerat 6-8 hourly from the day 2-14 of the menstrual cycle . Estrogen and progesterone (prontogest 400mg pessaries ) are given 3 days prior to embryo transfer. Sildenafil is discontinued 48-72 hours prior to the embryo transfe due sildenafil may have some detrimental effects on endometrium in the implantation window

Detailed Description

A total of 80 Patients who meet these conditions will enter the study and be divided into two groups based on randomized tables.

To prepare the endometrium,

Group A : 40 women are given oral estradiol valerate tablets 2mg 6-8 hourly from the day 2-14 of the cycle to prepare the endometrium

Group B : 40 women are give sildenafil citrate 25mg vaginally every 6 hours (a half of 50 mg tablet is crushed and dissolved in 2cc of distilled water and injected in to vagina) starting from day 2-14 of the cycle, in addition to oral 2mg of estradiol valerat 6-8 hourly from the day 2-14 of the menstrual cycle . Estrogen and progesterone (prontogest 400mg pessaries ) are given 3 days prior to embryo transfer. Sildenafil is discontinued 48-72 hours prior to the embryo transfe due sildenafil may have some detrimental effects on endometrium in the implantation window.

For assessing endometrial vascularity (on day 14 of cycle), two dimension power Doppler characteristics as normal quality of color, color gain-3.4, pulse repetition frequency of 600Hz and wall motion filter of 50Hz are applied in all examinations. By following Applebaum's zones of vascularity for categorizing endometrial vasculaity: Zone 1 vascularity-When blood vessls reach the hypoechoic endometrio-myometria junction, Zone 2 vascularity when the vessels reach the outer hyperechoic line of en-dometrium, Zone 3 vascularity when it reach the intervening hypoechoic area, Zone 4 vascularity when the vessels are seen reaching the central echogenic line .

After 5 days when the endometrial pattern is triple line pattern (trilaminar) and endometrial thickness is more than 8mm,embryos will be transferred. All patients have a luteal phase support by giving a daily doses of estradiol valerat 2mg oral daily and 100mg progesterone (prontogest 100mg ampoule ) as an intramuscular which will be continued two weeks after the em-bryos transfer. In case BHCG is tested and proved to be positive, estradiol valerat and progesterone are continueed until the 11th week of pregnancy. Then, four weeks after the embryo transfer, the number of gestational sacs are determined by vaginal ultrasound.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Sildenafil group

40 women are give sildenafil citrate 25mg vaginally every 6 hours (a half of 50 mg tablet is crushed and dissolved in 2cc of distilled water and injected in to vagina) starting from day 2-14 of the cycle, in addition to oral 2mg of estradiol valerat 6-8 hourly from the day 2-14 of the menstrual cycle

Group Type: ACTIVE_COMPARATOR

sildenafil citrate

Intervention Type: DRUG

25mg vaginally every 6 hours (a half of 50 mg tablet is crushed and dissolved in 2cc of distilled water and injected in to vagina) starting from day 2-14 of the cycle

Estradiol Valerate 2 MG

Intervention Type: DRUG

2mg 6-8 hourly from the day 2-14 of the cycle to prepare the endometrium

estradiol group

40 women are given oral estradiol valerate tablets 2mg 6-8 hourly from the day 2-14 of the cycle to prepare the endometrium in addition to placebo in the same way as sildenafil

Group Type: ACTIVE_COMPARATOR

Estradiol Valerate 2 MG

Intervention Type: DRUG

2mg 6-8 hourly from the day 2-14 of the cycle to prepare the endometrium

Interventions

sildenafil citrate

25mg vaginally every 6 hours (a half of 50 mg tablet is crushed and dissolved in 2cc of distilled water and injected in to vagina) starting from day 2-14 of the cycle

Intervention Type: DRUG

Estradiol Valerate 2 MG

2mg 6-8 hourly from the day 2-14 of the cycle to prepare the endometrium

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Women undergoing their first frozen embryo transfer cycle.
• have at least two high quality frozen embryos

Exclusion Criteria

• 1. a history of endocrine diseases. 2. a history of hysteroscopic surgeries. 3. cardiovascular, renal and liver diseases. 4. hypotension (blood pressure <90/50 mmHg). 5. a history of stroke or myocardial infarction.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed M Maged, MD

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Maged, MD

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

Kasr Alainy medical school

Cairo, , Egypt

Countries

Egypt

Central Contacts

Ahmed Maged, MD

Role: CONTACT

prof.ahmedmaged@gmail.com

+201005227404

Ahmed Said, MSc

Role: CONTACT

Medo_said14@yahoo.com

01013903948

Other Identifiers

51

Identifier Type: -

Identifier Source: org_study_id