Efficacy Study Comparing the Effect of Clomiphencitrate to an Antagonist Protocol (CANTAPOR)
Primary Purpose
Female Infertility, Ovarian Insufficiency
Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
High Dose Clomiphencitrat
Low Dose Clomiphencitrat
High Dose Placebo
Low dose Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Female Infertility focused on measuring female infertility, poor ovarian response, controlled ovarian hyperstimulation, IVF, Antagonist protocol
Eligibility Criteria
Inclusion Criteria:
- Age: >18 years < 43 years
- BMI: ≥ 18 ≤ 32 kg/m2
- Poor responder as defined by ESHRE working group
Exclusion Criteria:
- Age < 18 und > 43 years
- Pregnancy
- Breast feeding
- Uterine conditions interfering with endometrial proliferation and embryo implantation (submucous fibroids or polyps)
- Women diagnosed with PCOS according to the Rotterdam criteria
- Hyperprolactinaemia - untreated
- Both ovaries not accessible transvaginally for oocyte pick up
- Ovarian cysts of unclear dignity
- Evidence of hydrosalpinx on ultrasound
- Clinically significant severe systemic disease that are incompatible with pregnancy
- Known or suspected hypersensitivity to the active substances (gonadotrophins, ganirelix, progesterone, clomiphencitrate)
- Untreated thyroid or adrenal disorders
- Bleeding disorders
- Cancer
- Severe renal or hepatic dysfunction
- Necessity to take medication that could influence ovarian stimulation
- History of OHSS in prior IVF cycle
Sites / Locations
- University Hospital Basel
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Placebo Comparator
Arm Label
High Dose Clomiphencitrat
Low Dose Clomiphencitrat
High Dose Placebo
Low Dose Placebo
Arm Description
450 IU Merional® plus 100mg Serophene®
150 IU Merional® plus 100mg Serophene®
450 IU Merional® plus Placebo
150 IU Merional® plus Placebo
Outcomes
Primary Outcome Measures
number of collected oocytes
Secondary Outcome Measures
Implantation rate
Full Information
NCT ID
NCT01577472
First Posted
April 5, 2012
Last Updated
December 3, 2018
Sponsor
University Hospital, Basel, Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT01577472
Brief Title
Efficacy Study Comparing the Effect of Clomiphencitrate to an Antagonist Protocol
Acronym
CANTAPOR
Official Title
Prospective Randomized Phase IV Study Comparing the Effect of Adding Clomiphencitrate Versus Placebo to a High Dose Versus a Minimal Dose GnRH Antagonist Protocol on the Number of Oocytes Collected From Women That Are Poor Responders
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
August 2013 (Actual)
Primary Completion Date
November 14, 2017 (Actual)
Study Completion Date
November 14, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study is to assess the oocyte yield of infertile women with suspected or known poor ovarian reserve (POR) undergoing a GnRH antagonist protocol for IVF with Merional® starting either with a low (150 IU) or a high dose (450 IU) and adding 100mg of CC (Serophene®) in the early follicular phase of the stimulation (day 3 to 7). To date no RCT has been conducted to compare the reproductive outcome of patients with POR as defined by the ESHRE Bologna criteria after controlled ovarian hyperstimulation with HMG in an GnRH antagonist protocol using low doses versus high doses of HMG and adding CC versus placebo. We hypothesize that adding 100 mg of CC on day 3-7 to a HMG antagonist protocol will lead to an additional increment of endogenous GT thus increasing the oocytes yield after controlled ovarian stimulation due to higher endogenous gonadotropin secretion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Infertility, Ovarian Insufficiency
Keywords
female infertility, poor ovarian response, controlled ovarian hyperstimulation, IVF, Antagonist protocol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
117 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Dose Clomiphencitrat
Arm Type
Active Comparator
Arm Description
450 IU Merional® plus 100mg Serophene®
Arm Title
Low Dose Clomiphencitrat
Arm Type
Active Comparator
Arm Description
150 IU Merional® plus 100mg Serophene®
Arm Title
High Dose Placebo
Arm Type
Placebo Comparator
Arm Description
450 IU Merional® plus Placebo
Arm Title
Low Dose Placebo
Arm Type
Placebo Comparator
Arm Description
150 IU Merional® plus Placebo
Intervention Type
Drug
Intervention Name(s)
High Dose Clomiphencitrat
Intervention Description
100mg of clomiphencitrate(Serophene®) are added to a high dose of HMG (450 IU of Merional®) in the early follicular phase of the stimulation (day 3 to 7).
Intervention Type
Drug
Intervention Name(s)
Low Dose Clomiphencitrat
Intervention Description
100mg of clomiphencitrate(Serophene®) are added to a low dose of HMG (150 IU of Merional®) in the early follicular phase of the stimulation (day 3 to 7).
Intervention Type
Drug
Intervention Name(s)
High Dose Placebo
Intervention Description
Placebo is added to a high dose of HMG (450 IU of Merional®) in the early follicular phase of the stimulation (day 3 to 7).
Intervention Type
Drug
Intervention Name(s)
Low dose Placebo
Intervention Description
Placebo is added to a low dose of HMG (150 IU of Merional®) in the early follicular phase of the stimulation (day 3 to 7).
Primary Outcome Measure Information:
Title
number of collected oocytes
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Implantation rate
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
43 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age: >18 years < 43 years
BMI: ≥ 18 ≤ 32 kg/m2
Poor responder as defined by ESHRE working group
Exclusion Criteria:
Age < 18 und > 43 years
Pregnancy
Breast feeding
Uterine conditions interfering with endometrial proliferation and embryo implantation (submucous fibroids or polyps)
Women diagnosed with PCOS according to the Rotterdam criteria
Hyperprolactinaemia - untreated
Both ovaries not accessible transvaginally for oocyte pick up
Ovarian cysts of unclear dignity
Evidence of hydrosalpinx on ultrasound
Clinically significant severe systemic disease that are incompatible with pregnancy
Known or suspected hypersensitivity to the active substances (gonadotrophins, ganirelix, progesterone, clomiphencitrate)
Untreated thyroid or adrenal disorders
Bleeding disorders
Cancer
Severe renal or hepatic dysfunction
Necessity to take medication that could influence ovarian stimulation
History of OHSS in prior IVF cycle
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca E Moffat, MD
Organizational Affiliation
University Hospital Basel, Women's Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
33367742
Citation
Moffat R, Hansali C, Schoetzau A, Ahler A, Gobrecht U, Beutler S, Raggi A, Sartorius G, De Geyter C. Randomised controlled trial on the effect of clomiphene citrate and gonadotropin dose on ovarian response markers and IVF outcomes in poor responders. Hum Reprod. 2021 Mar 18;36(4):987-997. doi: 10.1093/humrep/deaa336.
Results Reference
derived
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Efficacy Study Comparing the Effect of Clomiphencitrate to an Antagonist Protocol
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