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Benefit of GnRH Agonist Before Frozen Embryo Transfer in Patients With Endometriosis and/or Adenomyosis (DECATEC Trial)
Phase 2 & 3
Recruiting
Led By Jean-Marc Ayoubi, Pr
Research Sponsored by Hopital Foch
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 months
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
Summary
Women suffering from endometriosis and/or adenomyosis may also suffer from infertility. GnRH agonist injection could improve implantation and therefore increase the pregnancy rate in these patients. This study was designed to evaluate effects of the additional of GnRH agonist (single or 2 doses) to the routine oestrogens and progestins use as support before Frozen Embryon Transfer as compared to oestrogens and progestins only.
Eligible Conditions
- Female Infertility
- Aromatase Inhibitor vs Gonadotropin Releasing Hormone Agonists for Uterine Adenomyosis
- Endometriosis
- Adenomyosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Clinical pregnancy rate in both groups at last visit ultrasound
Secondary study objectives
Rates of miscarriages on the number of patients included
Side effects related to treatment with Decapeptyl 3 mg
Successful implantation rate on the number of patients included
Side effects data
From 2014 Phase 3 trial • 645 Patients • NCT0007900162%
Fatigue
54%
Myalgia
25%
Creatinine increased
23%
Nausea
20%
Diarrhea
19%
Serum calcium decreased
17%
Anorexia
14%
Fever
14%
Serum potassium decreased
13%
Vomiting
12%
Chills
12%
Serum phosphate decreased
12%
Rash desquamating
7%
Serum magnesium decreased
7%
Pruritus
6%
Bone pain
5%
Alkaline phosphatase increased
5%
Back pain
4%
Blood glucose increased
3%
Hemoglobin decreased
3%
Hypersensitivity
3%
Osteonecrosis
3%
Erectile dysfunction
2%
Dyspnea
2%
Urinary retention
2%
Myocardial ischemia
2%
Renal failure
2%
Constipation
2%
Leukocyte count decreased
2%
Serum sodium decreased
2%
Arthralgia
2%
Insomnia
1%
Cough
1%
Testicular pain
1%
Pain in extremity
1%
Treatment related secondary malignancy
1%
Cardiac disorder
1%
Small intestinal obstruction
1%
Abdominal pain
1%
Lower gastrointestinal hemorrhage
1%
Disease progression
1%
Pain
1%
Bladder infection
1%
Sudden death
1%
Fracture
1%
Urinary tract infection
1%
Laboratory test abnormal
1%
Lymphocyte count decreased
1%
Neutrophil count decreased
1%
Dehydration
1%
Muscle weakness
1%
Musculoskeletal disorder
1%
Dizziness
1%
Syncope vasovagal
1%
Peripheral motor neuropathy
1%
Ureteric obstruction
1%
Hypertension
1%
Hemolysis
1%
Cataract
1%
Infection
1%
Pneumonia
1%
Skin infection
1%
Alanine aminotransferase increased
1%
Serum albumin decreased
1%
Serum magnesium increased
1%
Dysgeusia
1%
Headache
1%
Urinary frequency
1%
Hot flashes
100%
80%
60%
40%
20%
0%
Study treatment Arm
Zoledronic Acid + Androgen Deprivation Therapy
Placebo + Androgen Deprivation Therapy
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Frozen embryo transfer with HRT and GnRH agonistExperimental Treatment1 Intervention
Patient will received 1 or 2 injection of GnRH agonist priori to usual Hormonal Replacement Therapy for a Frozen embryo transfer composed of estrogens and progestins.
Group II: Frozen embryo transfer with Hormonal Replacement Therapy (HRT)Active Control1 Intervention
Patient will received usual Hormonal Replacement Therapy for a Frozen embryo transfer composed of estrogens and progestins.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Triptorelin
FDA approved
Find a Location
Who is running the clinical trial?
Hopital FochLead Sponsor
213 Previous Clinical Trials
55,999 Total Patients Enrolled
Paul Pirtea, DrStudy DirectorHopital Foch
Jean-Marc Ayoubi, PrPrincipal InvestigatorHopital Foch