Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01331733
Other study ID # FER-MEN-2006-01
Secondary ID
Status Completed
Phase N/A
First received April 6, 2011
Last updated April 7, 2011
Start date November 2006
Est. completion date March 2009

Study information

Verified date April 2011
Source Ferring Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority Spain: Agencia Española de Medicamentos y Productos Sanitarios
Study type Observational

Clinical Trial Summary

To assess the effectiveness of protocols of ovarian hyperstimulation combining urinary gonadotrophins + GnRH antagonist vs urinary gonadotrophins, to achieve clinical pregnancy in females undergoing intrauterine insemination.

Study hypothesis: protocols combining urinary gonadotrophins + GnRH antagonist should be more effective than monotherapy.


Recruitment information / eligibility

Status Completed
Enrollment 131
Est. completion date March 2009
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 36 Years
Eligibility Inclusion Criteria:

- Women aged 18-36 years

- Body mass index (BMI) between 18 and 26

- Prolactin within the laboratory normal range

- Couples affected by sterility able to treat by IUI (intrauterine insemination)

- Patients undergoing Menopur® treatment

- Normal thyroid function

- Regular menses (21-35 days)

- Couples willing to participate in the study that have signed the informed consent form

- Seminal sample REM>3 million

Exclusion Criteria:

- Two previous ART (assisted reproductive technology) cycles without ongoing pregnancy

- Policystic ovarian syndrome

- Evidence of significant bacterial infection in the seminogram of the couple in the preceding 6 months

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Drug:
hMG-HP

hMG + GnRH antagonist


Locations

Country Name City State
Spain Investigational site Barcelona
Spain Investigational site Ciudad Real
Spain Investigational site Gerona
Spain Investigational site La Rioja
Spain Investigational site Navarra
Spain Investigational site Reus Tarragona
Spain Investigational site Valladolid

Sponsors (2)

Lead Sponsor Collaborator
Ferring Pharmaceuticals Ferring SAU

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical pregnancy rate 30 days No
Secondary Live birth rate 40 weeks No
See also
  Status Clinical Trial Phase
Completed NCT01955356 - Embryo Implantation After Induced Endometrial Injury N/A
Completed NCT01330784 - Assessment of the Therapeutic Utility of hMG-HP N/A
Completed NCT01330771 - Assessment of the Therapeutic Utility of r-FSH in Association With hMG-HP N/A
Active, not recruiting NCT05079685 - HyFoSy Versus HSG as a Diagnostic Technique for Tubal Patency.
Completed NCT04605003 - Effectiveness of Nasal Endoscope Sterilization Using a Novel Rig-S™ Device N/A
Completed NCT02607319 - Low Molecular Weight Heparin to Improve Pregnancy Outcome in Patients With Recurrent Implantation Failure Phase 4
Completed NCT01331720 - Assessment of the Effectiveness and Tolerability of Ovarian Hyperstimulation N/A
Not yet recruiting NCT02648555 - A Lifestyle Intervention to Improve in Vitro Fertilization Results N/A
Suspended NCT00749853 - Efficacy of Ovarian Stimulation Based on FSHR Genotype Status Phase 3
Recruiting NCT03177122 - Myo-Inositol- Based Co-treatment in Women With PCOS Undergoing Assisted Reproductive Technology Phase 4
Completed NCT03169166 - The Use of GnRH Agonist Trigger for Final Follicle Maturation in Women Undergoing Assisted Reproductive Technologies Phase 4
Completed NCT01406964 - Chlamidia Antibodies Test for Tubal Factor Screening N/A
Completed NCT01430650 - Endometrial Priming for Embryo Transfer Phase 4
Completed NCT03173404 - Benefits of Hysteroscopy Prior to Performing a Cycle of in Vitro Fertilization/Intracytoplasmic Sperm Injection N/A
Completed NCT03561129 - Embryotransfer Operator and Pregnancy Rate
Recruiting NCT05173597 - Real-world Evidence on Follitropin Delta Individual Dosing
Recruiting NCT04026282 - To Investigate the Cumulative Live Birth Rates Using GnRH Antagonist or Agonist Protocol for COS in ART Treatment N/A
Completed NCT03619707 - Oral Versus Vaginal Progesterone in the Luteal Support in Cryo-warmed Embryo Transfer Cycles Phase 4