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

Infertility, Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03476564
• Other study ID #: BenhaU1
• Status: Not yet recruiting
• Phase: Early Phase 1
• First received: March 2, 2018
• Last updated: March 18, 2018
• Start date: May 1, 2018
• Est. completion date: September 1, 2018

Study information

• Verified date: March 2018
• Source: Benha University
• Contact: ahmed amr fayez, M.B.B.CH
• Phone: (002)01066653186
• Email: ahmed_fayez275[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: September 1, 2018
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 39 Years

Eligibility

Inclusion Criteria:

• infertile female patients under 39 years

Exclusion Criteria:

• hypothalamic amenorrhea

• drug reactions or complications

• endometrioses

• fibroids

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

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
• 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

Locations

Country	Name	City	State
Egypt	El Galaa Teaching hosptial	Cairo	Ghamra

Sponsors (3)

Lead Sponsor	Collaborator
Benha University	Benha University Hospital, El Galaa Teaching Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical pregnancy rate.	serum beta-hCG analysis 14 days after embryo transfer	two weeks after embryo transfer
Primary	clinical pregnancy rate	transvaginal ultrasound scan will be scheduled 2 weeks after embryo transfer to confirm the diagnosis of clinical pregnancy	two weeks after embryo transfer