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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01112358
Other study ID # IMP26170 (INI25954)
Secondary ID 2005-002229-30
Status Completed
Phase Phase 2
First received
Last updated
Start date December 7, 2005
Est. completion date January 30, 2007

Study information

Verified date July 2018
Source Merck KGaA
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Evaluate the effectiveness of adding lutropin alfa (recombinant human luteinizing hormone [r-hLH]) in the middle of the follicular phase compared to no addition, in infertile women at risk of poor response stimulated with follitropin alfa (recombinant Follicle-Stimulating Hormone [r-FSH]) under Gonadotropin Releasing Hormone (GnRH) antagonist in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI), in the number and quality of oocytes, follicular development, fertilization oocyte, embryo quality, and pregnancy rate.


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date January 30, 2007
Est. primary completion date January 30, 2007
Accepts healthy volunteers No
Gender Female
Age group N/A to 38 Years
Eligibility Inclusion Criteria:

- Participants who were at risk of poor response by at least one of the following criteria: a) <3 follicles in last cycle, or less than or equal to (</=) 2 metaphase II oocytes, or estradiol (E2) <600 pg/mL; b) Cancellation of previous cycle; c) Early follicular serum Follicle-Stimulating Hormone (FSH) >8.5 milli IU/L

- Participants with normal baseline luteinizing hormone and E2 levels

- Regular menstrual cycles of 25-35 days

- Presence of both ovaries and uterus able to withstand pregnancy

Exclusion Criteria:

- Participants who had any clinically significant disease including known human immunodeficiency virus (HIV), hepatitis-B virus (HBV)/hepatitis-C virus (HCV) positivity

- Participants with more than 3 previous assisted reproductive techniques (ART) cycles

- Participants with polycystic ovaries or cyst of unknown etiology; unexplained gynecological bleeding

- Participants who had any contraindication to being pregnant

- Active substance abuse

- Participants who had simultaneously participated in another clinical drug trial

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
r-FSH
r-FSH will be administered as specified in the arm description.
r-hLH
r-hLH will be administered as specified in the arm description.
Analogous GnRH antagonist
Analogous GnRH antagonist will be administered as specified in the arm description.
r-hCG
r-hCG will be administered as specified in the arm description.
Progesterone
Progesterone will be administered as specified in the arm description.

Locations

Country Name City State
Spain Hospital Universitario de La Fe Valencia

Sponsors (1)

Lead Sponsor Collaborator
Merck KGaA

Country where clinical trial is conducted

Spain, 

References & Publications (1)

M.J. Fernández Ramírez, A. Monzó, T. García-Gimeno, J.M. Rubio, V. Montañana, C. Duque, G. Herrero, A. Romeu. Role of LH administration during the follicullar phase in women with risk of low response in ovarian stimulation with FSH and cetrorelix for IVF,

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Oocytes Retrieved At the end of stimulation (Day 2 up to Day 8)
Primary Number of Follicles Greater Than (>) 14 Millimeter (mm) in Diameter At the end of stimulation (Day 2 up to Day 8)
Primary Oocytes Recovery Rate Oocytes recovery rate (oocytes per >14 mm follicle) is defined as number of oocytes retrieved divided by number of follicles >14 mm in diameter. At the end of stimulation (Day 2 up to Day 8)
Secondary Oocyte Nuclear Maturity Rate Oocyte nuclear maturity rate (metaphase II oocytes per retrieved oocyte) is defined as number of metaphase II oocytes divided by total number of oocytes retrieved. At the end of stimulation (Day 2 up to Day 8)
Secondary Fertilization Rate The fertilization rate (2 pronuclei [PN] fertilized oocytes per inseminated oocyte) was defined as number of 2 PN fertilized oocytes divided by number of inseminated oocytes. Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)
Secondary Number of Embryos by Quality Embryo quality was graded according to morphological classification of Veeck. Grade 1: even blastomeres with no fragmentation; Grade 2: even blastomeres with slight fragmentation (less than 20%); Grade 3: uneven size blastomeres with no fragmentation; Grade 4: even or uneven size blastomeres with moderate fragmentation (20-25%); and Grade 5: unrecognizable blastomeres with severe fragmentation (>50%). Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)
Secondary Number of Embryos Transferred by In Vitro Fertilization (IVF) Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)
Secondary Number of Participants With Positive Pregnancy Test The beta Human Chorionic Gonadotropin (beta-hCG) test was used as pregnancy test. Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)
Secondary Number of Participants With Clinical Pregnancy A clinical pregnancy is a pregnancy that is confirmed by both pregnancy test (beta-hCG test) and sonographic confirmation of a gestational sac or heartbeat (fetal sac). Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)
Secondary Implementation Rate Implementation rate (clinical pregnancy/embryo transferred) was defined as the number of clinical pregnancies divided by number of embryos transferred. Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)
Secondary Plasma Level of Estradiol At the time of r-hCG administration (any days between Day 2 to Day 8)
Secondary Endometrial Thickness At the time of r-hCG administration (any days between Day 2 to Day 8)
Secondary Duration of Ovarian Stimulation Duration of ovarian stimulation was defined as the time from start of study treatment to time of r-hCG administration. Randomization to Day 8
Secondary rFSH Cumulative Dose Randomization to Day 8
Secondary Plasma Levels of LH At the time of r-hCG administration (any days between Day 2 to Day 8)
Secondary Number of Participants in Whom At Least 1 Stimulation Cycle Was Cancelled Randomization to Day 8
See also
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