Analysis of Two Therapeutic With Cetrotide® in Polycystic Ovarian (PCO) Women in Assisted Reproductive Technology (ART)

Browse trials for

• Polycystic Ovary Syndrome 944

Keywords

• Cetrorelix acetate; follitropin alfa; human chorionic-gonadotropin alfa; follicular maturation; pregnancy; ovarian stimulation

Polycystic Ovary Syndrome

944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.

This study's enrollment of 136 is above the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.

Lead sponsor

Merck KGaA, Darmstadt, Germany is the lead sponsor of 269 studies on the registry; none are open to participants now.

Study arms

• Experimental
  Day 1 protocol

  Drug: Cetrorelix acetate · Drug: Recombinant Human Choriogonadotropin (r-hCG) · Drug: Recombinant human follicle stimulating hormone (r-hFSH)

• Experimental
  Day 7 protocol

  Drug: Cetrorelix acetate · Drug: Recombinant Human Choriogonadotropin (r-hCG) · Drug: Recombinant human follicle stimulating hormone (r-hFSH)

Interventions

• DrugCetrorelix acetate

  Cetrotide® 0.25 mg will be administered subcutaneously once daily from Day 1 (Day 0 of stimulation period \[S0\]) until r-hCG day (at least 2 follicles \>=17 mm)

  Also known as: Cetrotide®

• DrugCetrorelix acetate

  Cetrotide® 0.25 mg will be administered subcutaneously once daily from Day 7 (Day 6 of stimulation period \[S6\]) until r-hCG day (at least 2 follicles \>=19 mm)

  Also known as: Cetrotide®

• DrugRecombinant Human Choriogonadotropin (r-hCG)

  The r-hCG will be administered subcutaneously as a single dose of 250 microgram (mcg) on r-hCG day

  Also known as: Ovitrelle®

• DrugRecombinant human follicle stimulating hormone (r-hFSH)

  Recombinant human follicle stimulating hormone (r-hFSH) will be administered subcutaneously at a dose between 75 and 187.5 international unit (IU) once daily from Day 2 (Day 1 of stimulation period \[S1\]) until r-hCG day

Primary outcomes

1. Estradiol (E2) Levels on r-hCG Day

   Time frame: r-hCG day (end of stimulation cycle [approximately 15 days])

Secondary outcomes

1. Serum Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Levels

   Time frame: Day 1

2. Serum Estradiol (E2) Levels

   Time frame: Day 1

3. Serum Progesterone (P4) Levels

   Time frame: Day 1

4. Anti Mullerian Hormone (AMH) Levels

   Time frame: Day 0

5. Number of Follicles Greater Than or Equal (>=) to 17 mm (For Day 1 Protocol) or 19 mm (For Day 7 Protocol) on r-hCG Day

   Time frame: r-hCG day (end of stimulation cycle [approximately 15 days])

6. Number and Quality of Oocytes Retrieved

   Oocyte retrieval is a technique used in in-vitro fertilization (IVF) in order to remove oocytes from the ovary of the female participant, enabling fertilization outside the body. Oocytes were classified into 4 different categories based on their quality: mature, fractured, immature and inseminated oocytes.

   Time frame: Oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])

7. Total Dose of Recombinant Human Follicle Stimulating Hormone (r-hFSH)

   Time frame: Day 1 up to r-hCG day (end of stimulation cycle [approximately 15 days])

8. Percentage of Fertilized Oocytes Retrieved

   Oocytes were fertilized using Intra-cytoplasmic Sperm Injection (ICSI) technique which is an IVF procedure in which a single sperm is injected directly into an egg under a microscope.

   Time frame: Oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])

9. Number of Embryos

   Embryo is defined as the product of the zygote, two or three days after fertilization of the oocytes.

   Time frame: Day 2-3 post oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])

10. Number of Blastocysts

    Blastocyst is an embryo, five or six days after fertilization, with an inner cell mass, outer layer of trophectoderm and a fluid-filled blastocoele cavity.

    Time frame: Day 5-6 post oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])

11. Number of Transferred Embryos

    Embryo transfer is the procedure in which one or more embryos are placed in the uterus.

    Time frame: Day 2-3 post Oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])

12. Implantation Rate

    Implantation rate per reporting group was measured as the number of gestational sacs observed, divided by the number of embryos transferred multiplied by 100.

    Time frame: 5 weeks post oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])

13. Percentage of Participants With Clinical Pregnancy

    Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It excludes ectopic pregnancy.

    Time frame: 10 weeks post r-hCG day (end of stimulation cycle [approximately 15 days])

14. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. A Serious Adverse Event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. To avoid the participant/event combination double-count AEs and SAEs are reported separately.

    Time frame: Day 1 up to end of study (15 days post last administration of study drug)

Baseline characteristics