Endometrial Scratching in In Vitro Fertilization Cycles With Oocyte Donation

Subfertility Clinical Trial

Official title:

Randomized Prospective Study of Endometrial Injury in In Vitro Fertilization Cycles With Oocyte Donation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01842178
• Other study ID #: CIRH-OLE:2013
• Status: Withdrawn
• Phase: N/A
• First received: April 25, 2013
• Last updated: May 9, 2017
• Start date: April 2013
• Est. completion date: January 2017

Study information

• Verified date: May 2017
• Source: Centro de Infertilidad y Reproducción Humana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to evaluate the potential benefit in pregnancy rates produced by an endometrial scratching made in an IVF cycle prior to embryo transfer in patients with donated oocytes.

Description:

This is a randomized, comparative, prospective, double Blind study.

The First stage of this study consists of revising the patients medical records to identify possible candidates. Patients indicated are randomized into two groups: experimental and control. They are followed up to 12 week of pregnancy.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2017
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 50 Years

Eligibility

Inclusion Criteria:

• Do IVF cycle with donor eggs

• Will adjust to protocol for the study.

• Have signed informed consent

Exclusion Criteria:

• Clinically significant systemic disease, hypothalamic or pituitary tumors

• ovarian, uterine or breast cancer

• hormonal abnormalities and / or medical , biochemistry, hematology pathology, which might interfere with gonadotropin treatment.

• known positivity for human immunodeficiency virus (HIV), hepatitis C or B virus (HCV / HBV) of the candidate or her partner.

• Uterine Factor(submucosal fibroids, intramural fibroids> 4 cm)

• Hydrosalpinx

• Patients receiving immune treatment

• Positive Diagnosis Thrombophilia

• preimplantation genetic diagnosis needed

• In case of using marital sperm are excluded the following patients:Altered male karyotype, Altered Meiosis in testicular biopsy, Altered FISH, sperm Fragmentation> 45%

• Pregnancy contraindication

• Known allergy to preparations containing estrogens or any of its excipients.

• Simultaneous participation in another clinical trial with medication.

• Do not want or can not adjust to study protocol.

Related Conditions & MeSH terms

• Infertility
• Subfertility

Intervention

Procedure:
• scratching
Endometrial Injury Done between 18-24 days prior to embryo transfer cycle. Using transfer catheter. Introduction of the same to the uterine fundus. Systematic scrapping of the four uterine walls, lengthwise. Performed by a skilled doctor. Subsequent ultrasound control.

Locations

Country	Name	City	State
Spain	Centro de Infertilidad y Reproducción Humana	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Centro de Infertilidad y Reproducción Humana

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evolutionary pregnancy	telephone patient contact	12 weeks of pregnancy
Other	abortion	telephone contact of patients	6-12 week of pregnancy
Primary	biochemical pregnancy	Determination of human chorionic gonadotropin blood levels.	14-16 days post-follicular punction
Secondary	Clinical pregnancy	Ultrasound	6 pregnancy weeks