Efficacy Study Comparing the Effect of Clomiphencitrate to an Antagonist Protocol

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01577472

Acronym

CANTAPOR

Enrollment

117

Registered

2012-04-13

Start date

2013-08-31

Completion date

2017-11-14

Last updated

2018-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Female Infertility, Ovarian Insufficiency

Keywords

female infertility, poor ovarian response, controlled ovarian hyperstimulation, IVF, Antagonist protocol

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.

Interventions

DRUGHigh Dose Clomiphencitrat

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).

DRUGLow Dose Clomiphencitrat

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).

DRUGHigh Dose Placebo

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).

DRUGLow dose Placebo

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 design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 43 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
number of collected oocytes	1 year

Secondary

Measure	Time frame
Implantation rate	1 year

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026