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

Sponsor

Benha University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03476564

Collaborator

El Galaa Teaching Hospital (Other)

140

Enrollment

Location

Arms

Anticipated Duration (Months)

34.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Infertility, Female	Drug: pentoxifylline Drug: Vit E	Early Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Single (Participant)

Masking Description:

Computer generated random number table will be used for randomization. Group assignments will be placed in sealed opaque sequentially numbered envelopes

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

May 1, 2018

Anticipated Primary Completion Date :

Sep 1, 2018

Anticipated Study Completion Date :

Sep 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: 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 Other Names: Trental S.R. 400 mg/BD 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 Other Names: Vit E PHARCO 400 mg/BD
No Intervention: comparison group . The comparison group will not receive the above drugs. The main outcome measure will be clinical pregnancy rate.

Arm

Intervention/Treatment

Experimental: 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.

Drug: 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

Other Names:

Trental S.R. 400 mg/BD

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

Other Names:

Vit E PHARCO 400 mg/BD

No Intervention: comparison group

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

Outcome Measures

Primary Outcome Measures

clinical pregnancy rate. [two weeks after embryo transfer]
serum beta-hCG analysis 14 days after embryo transfer
clinical pregnancy rate [two weeks after embryo transfer]
transvaginal ultrasound scan will be scheduled 2 weeks after embryo transfer to confirm the diagnosis of clinical pregnancy

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 39 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

infertile female patients under 39 years

Exclusion Criteria:

hypothalamic amenorrhea
drug reactions or complications
endometrioses
fibroids

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	El Galaa Teaching hosptial	Cairo	Ghamra	Egypt

Sponsors and Collaborators

Benha University
El Galaa Teaching Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Amr Fayez, doctor, Benha University

ClinicalTrials.gov Identifier:

NCT03476564

Other Study ID Numbers:

BenhaU1

First Posted:

Mar 26, 2018

Last Update Posted:

Mar 26, 2018

Last Verified:

Mar 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Ahmed Amr Fayez, doctor, Benha University

assisted reproductive techniques

Additional relevant MeSH terms:

Infertility

Infertility, Female

Pentoxifylline

Study Results

No Results Posted as of Mar 26, 2018