Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03398993
Other study ID # 17
Secondary ID
Status Not yet recruiting
Phase N/A
First received January 8, 2018
Last updated January 8, 2018
Start date January 2018
Est. completion date December 2018

Study information

Verified date January 2018
Source Cairo University
Contact Ahmed maged
Phone +20201005227404
Email dr_ahmedmaged08@kasralainy.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

100 patient of unexplained infertility recruited and divided into two groups for the study group (50) endometrial scratching done in preovulatory period after controlled ovarian stimulation by clomiphene citrate , then followed and compared to control group for 6 months to asses pregnancy rate


Description:

Induction of ovulation was done by clomophine citrate (selective estrogen modulator of triphenylethylene group, produced by( Sanafi Aventis company) from 3rd day of cycle till 7th day of cycle and HMG 75IU (MerionaL) produced by IBSA ( Institute biochimique SA) given from 6th day of cycle till 8th of cycle once daily. folliculometry done regularly during induction of ovulation till dominant follicle reached 18_20mm in size.

Then endometrial injury performed in pre ovulatory day by a thin pipelle (a fine, flexible, sterile, plastic tube) produced by Jiangsu Guard King Medical Equipment Co.

The procedure was carried out in preovulatory day (known when dominant follicle reached 18_20 mm in diameter), usually, done around day 14-day of the cycle.

In the theatre, Patients put in a lithotomy position, sterilization was performed with the presence of good source of light., the procedure was carried out using a thin pipelle tube as follow :- A cuscoe's speculum was inserted into the vagina in order to visualize the cervix.

Cervix was grasped by vollselum upwards backwards, then pipelle tube passed through the cervix and uterine cavity, then moved up and down to make a single induced scratch two times in the lining endometrium of posterior wall of uterus.

The procedure took approximately 15minutes to complete. It was uncomfortable or painful in some circumstances and that bleeding after the procedure happened in many cases. Post procedure antibiotics were given.

Couples were advised to practice timed sexual intercourse for next 6months and couples in both groups were asked to phone a contact Person whenever there was a missed period. The patients followed up for six months for detecion of the biochemical pregnancy if occurred.

2- Control group (50patients) :- They received the same induction of ovulation as first group but without performing endometrial injury in preovulatory day.

We wait till time of period if missed period achieved serum pregnancy test done after one week of missed period .

All women followed for 6 months after treatment. Comparative study was done for both groups and results presented in tables and statistically analyzed


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 36 Years
Eligibility Inclusion Criteria:

- Unexplained infertility ( 1ry & 2ndry infertility) : *

- Normal hormonal profile of infertile woman.

- Normal hystrosalpingogram.

- Normal laparoscopy.

- Normal investigation of the cervical factor

- Fertile semen analysis (according to world health organization criteria 2015).

Exclusion Criteria:

- • Infertile semen analysis.

- Abnormal HSG.

- Abnormal laparoscopic findings.

- Disturbed hormonal profile.

- Evidence of cervical factor.

- Known genetic disorder

- Known autoimmune disease

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Clomiphene Citrate
50 mg twice daily from3rd day of cycle till 7th day of cycle
Human chorionic gonadotropin
75 IU dail;y from 6th day of cycle till 8th of cycle once daily
Device:
Endometrial scratch
The procedure was carried out in preovulatory day (known when dominant follicle reached 18_20 mm in diameter), usually, done around day 14-day of the cycle. In the theatre, Patients put in a lithotomy position, sterilization was performed with the presence of good source of light., the procedure was carried out using a thin pipelle tube as follow :- A cuscoe's speculum was inserted into the vagina in order to visualize the cervix. Cervix was grasped by vollselum upwards backwards, then pipelle tube passed through the cervix and uterine cavity, then moved up and down to make a single induced scratch two times in the lining endometrium of posterior wall of uterus. The procedure took approximately 15minutes to complete

Locations

Country Name City State
Egypt Kasr Alainy medical school Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary clinical pregnancy rate intrauterine gestational sac 4 weeks after missed period
See also
  Status Clinical Trial Phase
Recruiting NCT04169451 - IUI With Letrozole Versus in Natural Cycle N/A
Completed NCT01672801 - Nimodipine to Prevent LH Surge During Ovulation Induction: Blinded Placebo-controlled RCT N/A
Completed NCT01232465 - Impact of Sperm DNA Integrity on In Vitro Cycles N/A
Not yet recruiting NCT01237535 - Luteal Phase Support With Progesterone Versus Estrogen and Progesterone on Pregnancy Rates Phase 4
Completed NCT02272439 - Endocrine Disrupting Chemicals: Potential Effects on Male and Female Reproductive Health in Saskatchewan N/A
Terminated NCT00650754 - Study of Oral Dehydroepiandrosterone(DHEA) to Treat Previously Unexplained Infertility Phase 2/Phase 3
Recruiting NCT04754243 - New Protocol in Unexplained Infertility Phase 4
Completed NCT03018314 - Serum Kisspeptin Levels in Infertile Women N/A
Completed NCT02488434 - The Effects of Using Fertile Chip in Sperm Selection for Intracytoplasmic Sperm Injection in Unexplained Infertility Phase 3
Completed NCT02739516 - Dual FSH/HCG Trigger in Letrozole Stimulated Intrauterine Insemination Cycles in Women With Unexplained Infertility Phase 3
Completed NCT02628756 - Endometrial Injury in Women With Unexplained Infertility N/A
Completed NCT01044862 - Assessment of Multiple Intrauterine Gestations From Ovarian Stimulation Phase 3
Recruiting NCT03386552 - A Study of Lidocaine Pertubation as a Treatment for Unexplained Infertility Phase 2
Completed NCT04465045 - Unexplained Infertility Treated by Hysteroscopy-laparoscopy
Completed NCT03461601 - Uterine Flushing With Human Chorionic Gonadotrophin and Unexplained Infertility N/A
Completed NCT01859520 - Swim up and Gradient Methods Used in Assisted Reproduction Techniques on DNA Fragmentation of Spermatozoa N/A
Active, not recruiting NCT03828786 - Uterine Scratching in Intra-Uterine Insemination N/A
Completed NCT03397693 - Assessment of Endometrial Thickness & Subendometrial Perfusion by 3D Power Doppler in Women With Unexplained Infertility and PCOS.
Withdrawn NCT04955574 - Probiotic and Antibiotic Therapies in Women With Unexplained Infertility Phase 2
Completed NCT02861105 - The Effect of LMWH on ICSI in Patients With Unexplained Infertility and Negative Immunological Markers Phase 4