Female InfertilityPhase 4CANTAPORNCT01577472
Efficacy Study Comparing the Effect of Clomiphencitrate to an Antagonist Protocol
A Phase 4 study testing High Dose Clomiphencitrat and Low Dose Clomiphencitrat in people with Female Infertility and Ovarian Insufficiency, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Female Infertility, Ovarian Insufficiency
- What is being tested?
- High Dose Clomiphencitrat and Low Dose Clomiphencitrat
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 117 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2013to 14 Nov 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 43 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: >18 years < 43 years
- BMI: ≥ 18 ≤ 32 kg/m2
- Poor responder as defined by ESHRE working group
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Female Infertility, Ovarian Insufficiency
- Being tested
- High Dose Clomiphencitrat, Low Dose Clomiphencitrat, High Dose Placebo, Low dose Placebo
- Keywords
- female infertility, poor ovarian response, controlled ovarian hyperstimulation, IVF, Antagonist protocol
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Dose ClomiphencitratDrug
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).
Low Dose ClomiphencitratDrug
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).
High Dose PlaceboDrug
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).
Low dose PlaceboDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| High Dose Clomiphencitrat | Active comparator | 450 IU Merional® plus 100mg Serophene® Receives: Drug: High Dose Clomiphencitrat |
| Low Dose Clomiphencitrat | Active comparator | 150 IU Merional® plus 100mg Serophene® Receives: Drug: Low Dose Clomiphencitrat |
| High Dose Placebo | Placebo comparator | 450 IU Merional® plus Placebo Receives: Drug: High Dose Placebo |
| Low Dose Placebo | Placebo comparator | 150 IU Merional® plus Placebo Receives: Drug: Low dose Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of collected oocytes
Measured: 1 year
Secondary outcomes (1)
Implantation rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2012 (estimated)
- Study startAug 2013
- Primary completion14 Nov 2017
- Study completion14 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Female InfertilityStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebecca E Moffat, MD, Principal investigator, University Hospital Basel, Women's Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01577472
- Sponsor's protocol ID
- CANTAPOR_2012
- Acronym
- CANTAPOR
- Status last verified
- Dec 2018
- First submitted
- 5 Apr 2012
- Last updated
- 4 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33367742
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01577472
- Acronym / sponsor ID
- CANTAPOR / CANTAPOR_2012
- Conditions
- Female Infertility, Ovarian Insufficiency
- Keywords
- female infertility, poor ovarian response, controlled ovarian hyperstimulation, IVF, Antagonist protocol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Aug 2013 (actual)
- Primary completion
- 14 Nov 2017 (actual)
- Study completion
- 14 Nov 2017 (actual)
- First posted
- 13 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High Dose Clomiphencitrat | Active comparator | Drug: High Dose Clomiphencitrat450 IU Merional® plus 100mg Serophene® |
| Low Dose Clomiphencitrat | Active comparator | Drug: Low Dose Clomiphencitrat150 IU Merional® plus 100mg Serophene® |
| High Dose Placebo | Placebo comparator | Drug: High Dose Placebo450 IU Merional® plus Placebo |
| Low Dose Placebo | Placebo comparator | Drug: Low dose Placebo150 IU Merional® plus Placebo |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age: >18 years < 43 years
- BMI: ≥ 18 ≤ 32 kg/m2
- Poor responder as defined by ESHRE working group
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Dose Clomiphencitrat100mg 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). | Drug | High Dose Clomiphencitrat |
| Low Dose Clomiphencitrat100mg 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). | Drug | Low Dose Clomiphencitrat |
| High Dose PlaceboPlacebo is added to a high dose of HMG (450 IU of Merional®) in the early follicular phase of the stimulation (day 3 to 7). | Drug | High Dose Placebo |
| Low dose PlaceboPlacebo is added to a low dose of HMG (150 IU of Merional®) in the early follicular phase of the stimulation (day 3 to 7). | Drug | Low Dose Placebo |
Primary outcome
number of collected oocytes
Time frame: 1 year
1 secondary outcome
Implantation rate
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2018.
- Derived from this study: PubMed 33367742Moffat 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca E Moffat, MD principal investigator
University Hospital Basel, Women's Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing High Dose Clomiphencitrat and Low Dose Clomiphencitrat in people with Female Infertility and Ovarian Insufficiency, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of collected oocytes (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01577472, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2018.