Effects of Pentoxifylline and Vitamin E on Pregnancy Rate in Infertile Women Treated by ICSI:

NCT ID: NCT03476564

Last Updated: 2018-03-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2018-09-01

Brief Summary

Our findings will provide preliminary clinical evidence to suggest the new experimental treatment approaches, toward female factor infertility treatment with pentoxyfylline.

Detailed Description

This randomized clinical trial will be conducted on 140 infertile patients. The study is approved by the Ethical Committee of Benha obstetrics and Gynecology Department and will be initiated after achieving written consents of the participants. The study will include infertile patients under 39 years of age without a previous history of ICSI cycle. Exclusion criteria will be hypothalamic amenorrhea, drug reactions or complications, endometriosis and fibroids. Patients will be randomly divided into two equal groups. Computer generated random number table will be used for randomization. Group assignments will be placed in sealed opaque sequentially numbered envelopes. For each participant a questionnaire will be filled by the researchers. The questionnaire contained questions about age, duration of infertility, the type and cause of infertility. Data will be collected from questionnaires, clinical, laboratory notes and ultrasound reports. Endometrial thickness will be measured on the day of the HCG prescription in both groups by one of the two attending physicians. Chemical pregnancy will be detected by serum beta-hCG analysis 14 days after embryo transfer and transvaginal ultrasound scan will be scheduled 2 weeks later to confirm the diagnosis of clinical pregnancy. The intervention group will receive pentoxifylline (Trental S.R.) 400 mg/BD plus vit E (PHARCO) 400 mg/BD 2 cycles before starting ICSI cycle and the medication will be continued until the beta-hCG becomes positive or the cycle is cancelled. The comparison group will not receive the above drugs. The main outcome measure will be clinical pregnancy rate.

Sample size calculation Sample size was calculated using PASS® version 11 program, setting the type-1 error (α) at 0.05 and the power (1-β) at 0.8. Results from a previous study (Ashraf alesyan, 2009) showed that the incidence of pregnancy rate among ttt group was 57.1% while for control group it was 39.2%, with an effect size of 12%. Calculation according to these values produced a minimal sample size of 131 cases in each group.

Results

Results will be statistically analyzed.

Conditions

Infertility, Female

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

intervention group

intervention group will receive pentoxifylline (Trental S.R.) 400 mg/BD plus vit E (PHARCO) 400 mg/BD 2 cycles before starting ICSI cycle and the medication will be continued until the beta-hCG becomes positive or the cycle is cancelled.

Group Type: EXPERIMENTAL

pentoxifylline

Intervention Type: DRUG

will be given 2 cycles before starting ICSI cycle and the medication will be continued until the beta-hCG becomes positive or the cycle is cancelled

Vit E

Intervention Type: DRUG

will be given 2 cycles before starting ICSI cycle and the medication will be continued until the beta-hCG becomes positive or the cycle is cancelled

comparison group

. The comparison group will not receive the above drugs. The main outcome measure will be clinical pregnancy rate.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

pentoxifylline

will be given 2 cycles before starting ICSI cycle and the medication will be continued until the beta-hCG becomes positive or the cycle is cancelled

Intervention Type: DRUG

Vit E

will be given 2 cycles before starting ICSI cycle and the medication will be continued until the beta-hCG becomes positive or the cycle is cancelled

Intervention Type: DRUG

Other Intervention Names

Trental S.R. 400 mg/BD; Vit E PHARCO 400 mg/BD

Eligibility Criteria

Inclusion Criteria

• infertile female patients under 39 years

Exclusion Criteria

• hypothalamic amenorrhea
• drug reactions or complications
• endometrioses
• fibroids

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

El Galaa Teaching Hospital

OTHER

Sponsor Role: collaborator

Benha University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Amr Fayez

doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

El Galaa Teaching hosptial

Cairo, Ghamra, Egypt

Countries

Egypt

Central Contacts

ahmed amr fayez, M.B.B.CH

Role: CONTACT

ahmed_fayez275@yahoo.com

(002)01066653186

Other Identifiers

BenhaU1

Identifier Type: -

Identifier Source: org_study_id